Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528873
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
COMS for Chronic Ulcers Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
NAZARÉ Concurrent Optical and Magnetic Stimulation COMS for Treatment of Patients With Chronic Ulcers of Vascular Origin in a Real-world Setting Including Care at Patients Home a Prospective Randomized Controlled Assessor Blinded Phase IV Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
NAZARÉ
Brief Summary:
Chronic leg and foot ulcers are defined as wounds that fail to heal in a timely manner typically persisting for over 4 to 8 weeks without substantial healing despite standard care These ulcers often result from macro- and microvascular disorders the most common being chronic venous insufficiency CVI alone or with peripheral artery disease PAD or microangiopathy Despite different causes chronic vascular-origin wounds share similar biological traits and require the same physiological processes for healing
Vascular issues hinder blood perfusion reducing oxygen nutrients and growth factors leading to decreased energy metabolism and impaired cell functions necessary for proliferation extracellular matrix production angiogenesis and tissue regeneration Reduced blood supply also limits leukocyte function compromising the immune response and leading to persistent inflammation and infection Consequently these wounds cannot effectively heal showing prolonged inflammation persistent infections and cellular senescence
Best practice wound care includes compression therapy and physical activity for venous ulcers and angioplasty surgery or bypass for arterial ulcers These treatments aim to improve blood flow reduce venous stasis and enhance venous return Compression therapy and physical activity lower hydrostatic pressure in the lower limb while angioplasty and surgery remove arterial blockages or create new blood flow routes
Recent studies highlight the role of mechano-sensitive MS ion channels in skin cell processes and their dysfunction in dermatological disorders Magnetic stimulation can activate MS TRCP1 channels enhancing mitochondrial respiration and mitochondriogenesis via the Ca2CalModulinCaMNFATPGC-1α pathway Ca2-activated calmodulin also catalyzes nitric oxide NO promoting vasodilation and tissue perfusion
Bimodal red and near-infrared photobiomodulation can further increase mitochondrial respiration and ATP production by activating Cytochrome C oxidase and mitigating NO-induced downregulation This synergistic mechanism of concurrent optical and magnetic stimulation COMS may amplify Ca2 and NO-mediated processes like cell proliferation migration vasodilation and angiogenesis while resolving inflammation Thus COMS may offer a promising therapy for chronic inflammation-prone wounds
The effectiveness of COMS has yet to be validated in large-scale studies This proposal aims to assess the impact of COMS therapy combined with standard care versus standard care alone on healing wound closure recurrence pain quality of life economic outcomes and device usability in patients with venous leg ulcers VLU and VLU associated with PAD in a large-scale multicentric randomized controlled trial
Vascular issues hinder blood perfusion reducing oxygen nutrients and growth factors leading to decreased energy metabolism and impaired cell functions necessary for proliferation extracellular matrix production angiogenesis and tissue regeneration Reduced blood supply also limits leukocyte function compromising the immune response and leading to persistent inflammation and infection Consequently these wounds cannot effectively heal showing prolonged inflammation persistent infections and cellular senescence
Best practice wound care includes compression therapy and physical activity for venous ulcers and angioplasty surgery or bypass for arterial ulcers These treatments aim to improve blood flow reduce venous stasis and enhance venous return Compression therapy and physical activity lower hydrostatic pressure in the lower limb while angioplasty and surgery remove arterial blockages or create new blood flow routes
Recent studies highlight the role of mechano-sensitive MS ion channels in skin cell processes and their dysfunction in dermatological disorders Magnetic stimulation can activate MS TRCP1 channels enhancing mitochondrial respiration and mitochondriogenesis via the Ca2CalModulinCaMNFATPGC-1α pathway Ca2-activated calmodulin also catalyzes nitric oxide NO promoting vasodilation and tissue perfusion
Bimodal red and near-infrared photobiomodulation can further increase mitochondrial respiration and ATP production by activating Cytochrome C oxidase and mitigating NO-induced downregulation This synergistic mechanism of concurrent optical and magnetic stimulation COMS may amplify Ca2 and NO-mediated processes like cell proliferation migration vasodilation and angiogenesis while resolving inflammation Thus COMS may offer a promising therapy for chronic inflammation-prone wounds
The effectiveness of COMS has yet to be validated in large-scale studies This proposal aims to assess the impact of COMS therapy combined with standard care versus standard care alone on healing wound closure recurrence pain quality of life economic outcomes and device usability in patients with venous leg ulcers VLU and VLU associated with PAD in a large-scale multicentric randomized controlled trial
Detailed Description:
Background Chronic leg and foot ulcers are defined as wounds which fail to proceed through phases of wound healing in an orderly and timely manner to produce a durable structural functional and cosmetic closure Depending on care setting geographical region wounds are considered chronic if they persist over more than 4 to 8 weeks with no substantial wound healing under standard of care SOC treatment regimen
Among the most frequent causes for a delayed wound healing process are macro- and microvascular disorders The most common is a chronic venous insufficiency CVI either as standalone or in combination with peripheral artery disease PAD or microangiopathy Despite their differences in etiology chronic wounds of vascular origin share similar biological features and require promotion of the same physiological processes for wound healing The vascular constraints reduce blood perfusion and hinder appropriate cellular supply with oxygen nutrients and growth factors This leads to decreased energy metabolism and therefore impaired cellular performance required for cell proliferation extracellular matrix production angiogenesis and tissue regeneration Additionally reduced vascular supply decreases the number and ability of leukocytes to engage oxidative bursts limiting the capacity for efficient pathogen destruction and leading to tissue devitalization Consequently the immune response becomes insufficient to deal with the local pathogen load leading to ongoing inflammation in the wound area In summary chronic wounds of vascular origins are unable to run through processes of wound healing showing an inability to respond to local reparative stimuli of the wound environment prolonged inflammation persistent infections and cellular senescence
Best practice wound care emphasizes the utilization of compression therapy and physical activity for leg ulcers of venous etiology and angioplasty surgery or bypass operation for leg ulcers of arterial etiology both axes of care being guided by the integration of healthcare professionals clinical expertise with the best available clinical evidence Compression therapy and physical activity facilitate wound healing by reducing hydrostatic pressure in the lower limb mitigating venous stasis and enhancing venous return To improve the blood supply to the ulcer angioplasty and surgery aims to clear out a blockage from a leg artery endarterectomy while bypass operation aims to put in a new route for blood flow in the leg
Concurrent Optical and Magnetic Stimulation Recent publications have demonstrated the importance of mechano-sensitive MS ion channels in regulating processes such as skin cell proliferation differentiation and barrier formation and linked their dysfunction to dermatological disorders Magnetic stimulation has been shown to activate mechanosensitive TRCP1 channels whereby the resulting ion channel-mediated calcium fluxes stimulate mitochondrial respiration and associated mitochondriogenesis through activation of the Ca2CalModulinCaM NFATPGC-1α pathway Ca2-activated calmodulin has also been shown lead to the catalyzation of nitric oxide NO a potent mediator for vasodilation and tissue perfusion
The concurrent bimodal red and near-infrared photo biomodulation can further increase mitochondrial respiration and intracellular ATP production through activation of the Cytochrome C oxidase and mitigating its downregulation by increased levels of intracellular NO through its photo dissociation Through this synergistic mechanism COMS may offer a therapeutic option for amplifying Ca2 and NO mediated processes such as cell proliferation migration vasodilation and angiogenesis while helping to shift the cytokine profile towards resolution of inflammation Therefore COMS may offer a promising therapeutic approach to enable the transition toward healing of therapy refractory wounds that tend to stay in inflammatory phase The effectiveness of COMS has not yet been tested in a large-scale study We propose here to assess the impact of COMS therapySOC versus SOC only on healing wound closure wound recurrence pain quality of life economic outcomes and device usability in patients with venous leg ulcers VLU and VLU associated with PAD in a large-scale multicentric randomized controlled trial
Design This study is a post market phase IV clinical trial A multicentric randomized controlled trial design will be used 122 consecutive eligible patients with VLU or VLU associated with PAD cared in outpatient or home settings in Switzerland 6 sites France 1 site Germany 2 sites and Austria 2 sites will be included and randomly allocated to one of the two study groups Half of the participants will receive the standard of care control group and the other half will receive the standard of care supplemented with COMS treatment during the 8 first weeks post-inclusion intervention group Total study duration for each participant will be 24 weeks
The intervention is single-blinded ie it not blinded to participants and health care professionals but blinded to data assessors Analysis
The entire sample intervention and control groups will be described according to the data level in terms of their demographic and health data using descriptive statistics For the analysis of the different outcomes the proportions or mean values will be compared between control and intervention groups by using classical tests of hypotheses Additional analyses will be conducted to assess the change of the wound size over time and to compare groups The statistical software for data science STATA 170 SAS version 94 or later SAS Institute Inc Cary NC will be used for data analysis
Among the most frequent causes for a delayed wound healing process are macro- and microvascular disorders The most common is a chronic venous insufficiency CVI either as standalone or in combination with peripheral artery disease PAD or microangiopathy Despite their differences in etiology chronic wounds of vascular origin share similar biological features and require promotion of the same physiological processes for wound healing The vascular constraints reduce blood perfusion and hinder appropriate cellular supply with oxygen nutrients and growth factors This leads to decreased energy metabolism and therefore impaired cellular performance required for cell proliferation extracellular matrix production angiogenesis and tissue regeneration Additionally reduced vascular supply decreases the number and ability of leukocytes to engage oxidative bursts limiting the capacity for efficient pathogen destruction and leading to tissue devitalization Consequently the immune response becomes insufficient to deal with the local pathogen load leading to ongoing inflammation in the wound area In summary chronic wounds of vascular origins are unable to run through processes of wound healing showing an inability to respond to local reparative stimuli of the wound environment prolonged inflammation persistent infections and cellular senescence
Best practice wound care emphasizes the utilization of compression therapy and physical activity for leg ulcers of venous etiology and angioplasty surgery or bypass operation for leg ulcers of arterial etiology both axes of care being guided by the integration of healthcare professionals clinical expertise with the best available clinical evidence Compression therapy and physical activity facilitate wound healing by reducing hydrostatic pressure in the lower limb mitigating venous stasis and enhancing venous return To improve the blood supply to the ulcer angioplasty and surgery aims to clear out a blockage from a leg artery endarterectomy while bypass operation aims to put in a new route for blood flow in the leg
Concurrent Optical and Magnetic Stimulation Recent publications have demonstrated the importance of mechano-sensitive MS ion channels in regulating processes such as skin cell proliferation differentiation and barrier formation and linked their dysfunction to dermatological disorders Magnetic stimulation has been shown to activate mechanosensitive TRCP1 channels whereby the resulting ion channel-mediated calcium fluxes stimulate mitochondrial respiration and associated mitochondriogenesis through activation of the Ca2CalModulinCaM NFATPGC-1α pathway Ca2-activated calmodulin has also been shown lead to the catalyzation of nitric oxide NO a potent mediator for vasodilation and tissue perfusion
The concurrent bimodal red and near-infrared photo biomodulation can further increase mitochondrial respiration and intracellular ATP production through activation of the Cytochrome C oxidase and mitigating its downregulation by increased levels of intracellular NO through its photo dissociation Through this synergistic mechanism COMS may offer a therapeutic option for amplifying Ca2 and NO mediated processes such as cell proliferation migration vasodilation and angiogenesis while helping to shift the cytokine profile towards resolution of inflammation Therefore COMS may offer a promising therapeutic approach to enable the transition toward healing of therapy refractory wounds that tend to stay in inflammatory phase The effectiveness of COMS has not yet been tested in a large-scale study We propose here to assess the impact of COMS therapySOC versus SOC only on healing wound closure wound recurrence pain quality of life economic outcomes and device usability in patients with venous leg ulcers VLU and VLU associated with PAD in a large-scale multicentric randomized controlled trial
Design This study is a post market phase IV clinical trial A multicentric randomized controlled trial design will be used 122 consecutive eligible patients with VLU or VLU associated with PAD cared in outpatient or home settings in Switzerland 6 sites France 1 site Germany 2 sites and Austria 2 sites will be included and randomly allocated to one of the two study groups Half of the participants will receive the standard of care control group and the other half will receive the standard of care supplemented with COMS treatment during the 8 first weeks post-inclusion intervention group Total study duration for each participant will be 24 weeks
The intervention is single-blinded ie it not blinded to participants and health care professionals but blinded to data assessors Analysis
The entire sample intervention and control groups will be described according to the data level in terms of their demographic and health data using descriptive statistics For the analysis of the different outcomes the proportions or mean values will be compared between control and intervention groups by using classical tests of hypotheses Additional analyses will be conducted to assess the change of the wound size over time and to compare groups The statistical software for data science STATA 170 SAS version 94 or later SAS Institute Inc Cary NC will be used for data analysis
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