Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608303
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Macrophage Stimulating Factor in the Treatment of Diabetic Wounds
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Effectiveness and Safety of Topical Human Granulocyte Macrophage Stimulating Factor Gel in the Treatment of Diabetic Wounds During the Granulation Growth Phase
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With the aging of the population the incidence of diseases such as diabetes chronic atherosclerotic occlusion cerebrovascular disease and cancer is increasing year by year and has led to an increasing incidence of chronic wounds such as diabetic foot ischaemic ulcers venous ulcers pressure injuries and radiation ulcers In addition to the high age and chronic diseases that make the treatment of wounds difficult and long chronic wounds remain in the proliferative stage unable to carry out normal repair which is also an important reason for the prolonged healing of wounds which seriously affects the quality of life of patients and creates a huge social and family burden In the United States chronic hard-to-heal wounds exist in approximately 65 million people each year costing the healthcare system more than 25 billion annually and increasing each year with the increased prevalence of diabetes and other diseases that affect wound healing How to make chronic wounds heal quickly and well is a huge challenge that affects peopleamp39s access to health today
Macrophages are important cells involved in the inflammatory and proliferative phases of wounds and are thought to play a key role in regulating the inflammatory response of wounds and promoting wound repair and reconstruction Recombinant human granulocyte macrophage colony-stimulating factor rhGM-CSF as a multifunctional haematopoietic factor can stimulate the proliferation and differentiation of haematopoietic precursor cells to granulocyte macrophage and promote their peripheral transfer as well as enhance phagocytosis and secretion of granulocytes and macrophages Therefore rhGM-CSF is thought to have a possible positive role in the treatment of acute and chronic wounds and has been confirmed in several basic and clinical studies
Topical human granulocyte macrophage stimulating factor gel JinFuNing which has been approved and marketed by the state for the treatment of acute and chronic wounds is able to play a role in promoting wound repair neovascularisation and epithelial crawling and has already achieved a certain degree of efficacy in promoting wound healing This study accumulates clinical evidence-based medical evidence for more precise use of topical human granulocyte macrophage stimulating factor gel and explores the clinical efficacy and safety of Jinfuning in the granulation growth phase of diabetic wounds
Macrophages are important cells involved in the inflammatory and proliferative phases of wounds and are thought to play a key role in regulating the inflammatory response of wounds and promoting wound repair and reconstruction Recombinant human granulocyte macrophage colony-stimulating factor rhGM-CSF as a multifunctional haematopoietic factor can stimulate the proliferation and differentiation of haematopoietic precursor cells to granulocyte macrophage and promote their peripheral transfer as well as enhance phagocytosis and secretion of granulocytes and macrophages Therefore rhGM-CSF is thought to have a possible positive role in the treatment of acute and chronic wounds and has been confirmed in several basic and clinical studies
Topical human granulocyte macrophage stimulating factor gel JinFuNing which has been approved and marketed by the state for the treatment of acute and chronic wounds is able to play a role in promoting wound repair neovascularisation and epithelial crawling and has already achieved a certain degree of efficacy in promoting wound healing This study accumulates clinical evidence-based medical evidence for more precise use of topical human granulocyte macrophage stimulating factor gel and explores the clinical efficacy and safety of Jinfuning in the granulation growth phase of diabetic wounds
Detailed Description:
2 Approximately 40 people will participate in this study at the Wound Treatment Centre of Peking University Third Hospital
3 What is included in this study Study design prospective blinded evaluation randomised controlled study Inclusion criteria 1 Subjects aged 18-80 years 2 Confirmed diagnosis of type 1 or type 2 diabetes mellitus that meets the standard definition of the World Health Organization with glycaemic control and glycated haemoglobin HbA1c level of less than 10 prior to enrolment 3 Wound type belonging to the ulcer category 4 Wound etiology belonging to the diabetic wounds which are mainly due to the abnormalities of glucose resulting in poor or prolonged healing and needing to undergo standard wound treatment 5 the wound staging was in the granulation growth phase 6 voluntary participation in this study and signing the informed consent
Exclusion criteria 1 severe diseases such as acute infarction heart failure hepatitis shock and expiratory failure which had not been corrected 2 uncontrolled blood glucose fasting blood glucose ampgt 15 mmolL and glycated haemoglobin ampgt 12 3 active bleeding within the wound which could not be carried out with the conventional basic treatment regimen 4 serum albumin amplt 20 gL haemoglobin amplt 60 gL platelets amplt 50109 L 5 disseminated infection status being treated or about to be treated with antibiotics 6 subjects with advanced malignancy 7 active autoimmune disease 8 previous allergy to bioactive glass ointment dressings autogenous 9 subjects who are unable to cooperate or mentally challenged 10 subjects who in the judgement of the investigator have a clearly unremovable cause of affecting wound healing that is unsuitable for this study or unable to comply with the requirements of this study
Randomisation to groups was based on the staging of chronic wounds and only after the stage conditions were met
of granulation divided into 20 cases in the control group and 20 cases in the treatment group
You will be randomly assigned like a coin flip to either group with a 50 chance of being assigned to the control group the chance of being assigned to the treatment group is a 50 chance of being assigned to the treatment group Treatment Except for the use of topical human granulocyte macrophage stimulating factor gel the treatment and examination protocols will be consistent with the standard clinical protocols for the control group including but not limited to strict glycemic control antihypertensive lipid-lowering improvement of microcirculation anti-infective nutritive neurological systemic nutritional support local physiotherapy arterial intraluminal shaping debridement dead bone removal tendon probing and resection and negative pressure therapy
The study steps are as follows
1 Perform wound photography wound area measurement and recording and complete wound bed preparation wound hygiene effective debridement
2 Apply topical human granulocyte macrophage stimulating factor gel treatment
Control group clinical standard treatment protocol Treatment group on the basis of the clinical standard treatment protocol use topical human granulocyte macrophage stimulating factor gel to treat the wound for 2 weeks applied to the wound with a thickness of 2 mm if possible on the 7th-14th day after the application of the drug the debridement waste tissue will be sent for examination and improve the transcriptome Bulk RNA-seq analysis and detection or other proteins gene detection and immunofluorescence etc after the examination in accordance with the medical treatment Dispose of the tissue as medical waste
3 Clinical standard treatment plan For each wound according to the wound status stage size etiology and location the optimal treatment plan and necessary surgical treatment measures are selected in accordance with clinical diagnosis and treatment routines including but not limited to strict control of blood glucose lowering blood pressure lowering lipids improvement of microcirculation anti-infections nutritional neurotoxicity systemic nutritional support local physiotherapy arterial endoluminal shaping debridement dead bone removal tendon probing and resection and negative pressure treatment
Note Although the general principles of wound treatment are usually the same due to the variety of wound status stage size etiology and location each treatment plan must be tailored to address individualised problems in order to achieve a more effective wound repair and even then with the current technological capabilities of mankind some wounds will still have delayed healing or non-healing Therefore clinical observations must be based on standard treatment protocols in order to minimise additional factors affecting wound repair
This is a prospective blinded evaluation randomised controlled study and you may be randomly assigned to either the control or observation group You will know exactly which group you are in whether or not you are applying topical human granulocyte macrophage stimulating factor gel and you will be able to observe the healing process of your wound together
4 How long will this study last You participate in this study for 3 weeks with follow-up records to be completed on the day of treatment Day 0 Week 1 after treatment Day 7 Week 2 after treatment Day 14 and Week 3 after treatment Day 21 Wound area changes and safety indicators are observed at weekly follow-up visits Your regular follow-up appointments and medication changes will be our follow-up visits and will not add to the number of additional visits or costs if there are no special circumstances
You may choose to leave the study at any time without losing any of the benefits you would otherwise receive However if you decide to leave the study during the course of the study a check-up may be carried out after the withdrawal if necessary to take into account your safety concerns
5 What are the risks of participating in this study All subjects eligible for enrolment have chronic ulcer type wounds The wounds must all be rigorously prepared and the protocol will only be administered after your general condition has improved At this point you are enrolled in treatment and your overall risk is already low
In this study the investigators have added topical human granulocyte macrophage-stimulating factor gel to the optimal clinical regimen for the wounds in the Jinfuning group but the rest of the treatment is routine The optimal clinical regimen has been in place for several years and has been stable and reliable and has cured a large number of people However by joining this study it does not mean that you are guaranteed to be treated with Topical Human Granulocyte Macrophage Stimulating Factor HMMSF Gel and there is a 50 chance you will be given the Topical HMMSF Gel regimen
Topical human granulocyte macrophage stimulating factor gel mainly promotes the proliferation and differentiation of granulocyte macrophages improves the inflammatory state secretes a variety of wound repair proteins and factors and promotes the proliferation and repair of wounds non-local antimicrobial agents and the main risk of topical application is the occurrence of disseminated infection Strict wound hygiene effective bacterial reduction and debridement and the use of local antimicrobial agents must be carried out before application to minimise the risk of infection The patients enrolled in this trial were all patients with systemic infection or disseminated infection that had been controlled and entered the period of granulation growth and the local application of topical human granulocyte macrophage stimulating factor gel was conducive to accelerating the formation of new microvessels and the growth of local granulation tissues and the frequency of dressing changes was sufficient so that timely intervention could be made once signs of disseminated infection were detected and the clinic routinely had a series of measures to control the dissemination of infections
Secondly allergic reaction to topical human granulocyte macrophage stimulating factor gel After applying the dressing each patient was observed for 10-30 minutes without discomfort before being allowed to leave the hospital and the patient was told to return to the hospital if heshe felt unwell Each time the dressing is opened the wound oozing and the surrounding skin should be observed for allergic reactions such as rash and redness If an allergic reaction occurs different anti-allergic treatments will be given depending on the severity
Of course diabetic wounds are a worldwide problem with diverse etiologies and even with topical human granulocyte macrophage stimulating factor gel treatment they may still not heal In addition participants39 co-morbidities will not get better with Topical Human Granulocyte Macrophage Stimulating Factor Gel treatment If participants have multi-system diseases please take the medication on time to ensure that participants condition is stable and if there is a progression of participants co-morbidities please go to the appropriate department in time for treatment
If participants have an adverse reaction the study doctor will terminate the study depending on the severity
6 What are the benefits of participating in the study If the participants agree to participate in this study it is possible that the participants may have a benefit from wound treatment but the investigators cannot guarantee that participants will have such a benefit The investigators hope that the information gained from participants39 participation in this study will benefit the participants and other patients with the same condition in the future
7 What other medical options are available If the participants do not take part in this study participants will have conventional wound treatment If participants participate in this study there is a 50 chance that participants will be treated with topical human granulocyte macrophage stimulating factor gel in addition to participants39 regular treatment
8 Will my information be kept confidential The investigators will keep participants39 study records confidential as required by law Our laws provide for privacy data and security of authorised access Participants39 information will be de-identified in this study the investigators will represent participants with a unique number and their information will not be transferred to a third party Waste tissue specimens collected for this study will also be de-identified and destroyed after testing Their identity will not be disclosed when the research information and data obtained from this study are presented at scientific meetings or in scientific journals However their records may be reviewed to ensure that the study complies with applicable laws and regulations The reviewers will include the relevant national regulatory authorities and the Ethics Committee of the Third Hospital of Peking University Participants have the right to withdraw from this study at any time If participants withdraw the information already collected will not be used for this study and after withdrawal no more information related to the study will be collected
9 What about the cost of the study The treatment group needs to be treated with topical human granulocyte macrophage stimulating factor gel which will be provided by the drug manufacturer free of charge during the trial period Wound assessment information collection wound dressing changes examination and test items and follow-up visits are routine clinical practice
10 What compensation will I receive This study does not increase the cost of routine care and is not compensated
11 If a study-related injury occurs If participants suffer an injury as a result of their participation in the study Peking University Third Hospital will provide the necessary medical care and in accordance with applicable laws and regulations will cover the costs of direct treatment and appropriate compensation
12 Refusing to participate or withdrawing from the study Participation in the trial is voluntary and participants may refuse to participate or withdraw from the trial in any way at any stage of the trial without discrimination or retaliation and your medical treatment and rights will not be affected
If participants have a serious adverse reaction or if their study doctor feels that it is not in their best interest to continue in the study heshe may decide to withdraw participants from the study Participants will be notified promptly if this happens and their study doctor will discuss the other options participants have with you If their doctor feels that an abrupt discontinuation of the trial will affect your health heshe may ask participants to come to the hospital for a check-up before stopping the trial
3 What is included in this study Study design prospective blinded evaluation randomised controlled study Inclusion criteria 1 Subjects aged 18-80 years 2 Confirmed diagnosis of type 1 or type 2 diabetes mellitus that meets the standard definition of the World Health Organization with glycaemic control and glycated haemoglobin HbA1c level of less than 10 prior to enrolment 3 Wound type belonging to the ulcer category 4 Wound etiology belonging to the diabetic wounds which are mainly due to the abnormalities of glucose resulting in poor or prolonged healing and needing to undergo standard wound treatment 5 the wound staging was in the granulation growth phase 6 voluntary participation in this study and signing the informed consent
Exclusion criteria 1 severe diseases such as acute infarction heart failure hepatitis shock and expiratory failure which had not been corrected 2 uncontrolled blood glucose fasting blood glucose ampgt 15 mmolL and glycated haemoglobin ampgt 12 3 active bleeding within the wound which could not be carried out with the conventional basic treatment regimen 4 serum albumin amplt 20 gL haemoglobin amplt 60 gL platelets amplt 50109 L 5 disseminated infection status being treated or about to be treated with antibiotics 6 subjects with advanced malignancy 7 active autoimmune disease 8 previous allergy to bioactive glass ointment dressings autogenous 9 subjects who are unable to cooperate or mentally challenged 10 subjects who in the judgement of the investigator have a clearly unremovable cause of affecting wound healing that is unsuitable for this study or unable to comply with the requirements of this study
Randomisation to groups was based on the staging of chronic wounds and only after the stage conditions were met
of granulation divided into 20 cases in the control group and 20 cases in the treatment group
You will be randomly assigned like a coin flip to either group with a 50 chance of being assigned to the control group the chance of being assigned to the treatment group is a 50 chance of being assigned to the treatment group Treatment Except for the use of topical human granulocyte macrophage stimulating factor gel the treatment and examination protocols will be consistent with the standard clinical protocols for the control group including but not limited to strict glycemic control antihypertensive lipid-lowering improvement of microcirculation anti-infective nutritive neurological systemic nutritional support local physiotherapy arterial intraluminal shaping debridement dead bone removal tendon probing and resection and negative pressure therapy
The study steps are as follows
1 Perform wound photography wound area measurement and recording and complete wound bed preparation wound hygiene effective debridement
2 Apply topical human granulocyte macrophage stimulating factor gel treatment
Control group clinical standard treatment protocol Treatment group on the basis of the clinical standard treatment protocol use topical human granulocyte macrophage stimulating factor gel to treat the wound for 2 weeks applied to the wound with a thickness of 2 mm if possible on the 7th-14th day after the application of the drug the debridement waste tissue will be sent for examination and improve the transcriptome Bulk RNA-seq analysis and detection or other proteins gene detection and immunofluorescence etc after the examination in accordance with the medical treatment Dispose of the tissue as medical waste
3 Clinical standard treatment plan For each wound according to the wound status stage size etiology and location the optimal treatment plan and necessary surgical treatment measures are selected in accordance with clinical diagnosis and treatment routines including but not limited to strict control of blood glucose lowering blood pressure lowering lipids improvement of microcirculation anti-infections nutritional neurotoxicity systemic nutritional support local physiotherapy arterial endoluminal shaping debridement dead bone removal tendon probing and resection and negative pressure treatment
Note Although the general principles of wound treatment are usually the same due to the variety of wound status stage size etiology and location each treatment plan must be tailored to address individualised problems in order to achieve a more effective wound repair and even then with the current technological capabilities of mankind some wounds will still have delayed healing or non-healing Therefore clinical observations must be based on standard treatment protocols in order to minimise additional factors affecting wound repair
This is a prospective blinded evaluation randomised controlled study and you may be randomly assigned to either the control or observation group You will know exactly which group you are in whether or not you are applying topical human granulocyte macrophage stimulating factor gel and you will be able to observe the healing process of your wound together
4 How long will this study last You participate in this study for 3 weeks with follow-up records to be completed on the day of treatment Day 0 Week 1 after treatment Day 7 Week 2 after treatment Day 14 and Week 3 after treatment Day 21 Wound area changes and safety indicators are observed at weekly follow-up visits Your regular follow-up appointments and medication changes will be our follow-up visits and will not add to the number of additional visits or costs if there are no special circumstances
You may choose to leave the study at any time without losing any of the benefits you would otherwise receive However if you decide to leave the study during the course of the study a check-up may be carried out after the withdrawal if necessary to take into account your safety concerns
5 What are the risks of participating in this study All subjects eligible for enrolment have chronic ulcer type wounds The wounds must all be rigorously prepared and the protocol will only be administered after your general condition has improved At this point you are enrolled in treatment and your overall risk is already low
In this study the investigators have added topical human granulocyte macrophage-stimulating factor gel to the optimal clinical regimen for the wounds in the Jinfuning group but the rest of the treatment is routine The optimal clinical regimen has been in place for several years and has been stable and reliable and has cured a large number of people However by joining this study it does not mean that you are guaranteed to be treated with Topical Human Granulocyte Macrophage Stimulating Factor HMMSF Gel and there is a 50 chance you will be given the Topical HMMSF Gel regimen
Topical human granulocyte macrophage stimulating factor gel mainly promotes the proliferation and differentiation of granulocyte macrophages improves the inflammatory state secretes a variety of wound repair proteins and factors and promotes the proliferation and repair of wounds non-local antimicrobial agents and the main risk of topical application is the occurrence of disseminated infection Strict wound hygiene effective bacterial reduction and debridement and the use of local antimicrobial agents must be carried out before application to minimise the risk of infection The patients enrolled in this trial were all patients with systemic infection or disseminated infection that had been controlled and entered the period of granulation growth and the local application of topical human granulocyte macrophage stimulating factor gel was conducive to accelerating the formation of new microvessels and the growth of local granulation tissues and the frequency of dressing changes was sufficient so that timely intervention could be made once signs of disseminated infection were detected and the clinic routinely had a series of measures to control the dissemination of infections
Secondly allergic reaction to topical human granulocyte macrophage stimulating factor gel After applying the dressing each patient was observed for 10-30 minutes without discomfort before being allowed to leave the hospital and the patient was told to return to the hospital if heshe felt unwell Each time the dressing is opened the wound oozing and the surrounding skin should be observed for allergic reactions such as rash and redness If an allergic reaction occurs different anti-allergic treatments will be given depending on the severity
Of course diabetic wounds are a worldwide problem with diverse etiologies and even with topical human granulocyte macrophage stimulating factor gel treatment they may still not heal In addition participants39 co-morbidities will not get better with Topical Human Granulocyte Macrophage Stimulating Factor Gel treatment If participants have multi-system diseases please take the medication on time to ensure that participants condition is stable and if there is a progression of participants co-morbidities please go to the appropriate department in time for treatment
If participants have an adverse reaction the study doctor will terminate the study depending on the severity
6 What are the benefits of participating in the study If the participants agree to participate in this study it is possible that the participants may have a benefit from wound treatment but the investigators cannot guarantee that participants will have such a benefit The investigators hope that the information gained from participants39 participation in this study will benefit the participants and other patients with the same condition in the future
7 What other medical options are available If the participants do not take part in this study participants will have conventional wound treatment If participants participate in this study there is a 50 chance that participants will be treated with topical human granulocyte macrophage stimulating factor gel in addition to participants39 regular treatment
8 Will my information be kept confidential The investigators will keep participants39 study records confidential as required by law Our laws provide for privacy data and security of authorised access Participants39 information will be de-identified in this study the investigators will represent participants with a unique number and their information will not be transferred to a third party Waste tissue specimens collected for this study will also be de-identified and destroyed after testing Their identity will not be disclosed when the research information and data obtained from this study are presented at scientific meetings or in scientific journals However their records may be reviewed to ensure that the study complies with applicable laws and regulations The reviewers will include the relevant national regulatory authorities and the Ethics Committee of the Third Hospital of Peking University Participants have the right to withdraw from this study at any time If participants withdraw the information already collected will not be used for this study and after withdrawal no more information related to the study will be collected
9 What about the cost of the study The treatment group needs to be treated with topical human granulocyte macrophage stimulating factor gel which will be provided by the drug manufacturer free of charge during the trial period Wound assessment information collection wound dressing changes examination and test items and follow-up visits are routine clinical practice
10 What compensation will I receive This study does not increase the cost of routine care and is not compensated
11 If a study-related injury occurs If participants suffer an injury as a result of their participation in the study Peking University Third Hospital will provide the necessary medical care and in accordance with applicable laws and regulations will cover the costs of direct treatment and appropriate compensation
12 Refusing to participate or withdrawing from the study Participation in the trial is voluntary and participants may refuse to participate or withdraw from the trial in any way at any stage of the trial without discrimination or retaliation and your medical treatment and rights will not be affected
If participants have a serious adverse reaction or if their study doctor feels that it is not in their best interest to continue in the study heshe may decide to withdraw participants from the study Participants will be notified promptly if this happens and their study doctor will discuss the other options participants have with you If their doctor feels that an abrupt discontinuation of the trial will affect your health heshe may ask participants to come to the hospital for a check-up before stopping the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None