Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791449
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2021-03-04
Brief Title:
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overarching purpose of this study is to investigate the impact that exercise as delivered through a medically supervised outpatient cardiac rehabilitation program has on the wound healing process in Type 2 diabetics having foot ulcers classified as being Wound Ischemia foot Infection WIfI stage 2 or lower The criterion reference measure of diabetic foot ulcer wound healing is be the time required to reach the maturation phase of the wound healing cascade wound closure without drainage
Detailed Description:
This study uses a two-group repeated measures design Sixty volunteers will be recruited through the University of New Mexico UNM Center for Healing in the Lower Extremity CHILE clinic A letter explaining the study will be placed in the file of all diabetic foot ulcer DFU clients of CHILE clinic There is section to be completed by interested clientele RSVP and placed it in labelled box in the clinic office
A research team member collects box contents M-F and contacts all respondents using the preferred method provided on the RSVP to conduct an initial screening of inclusionexclusion criteria and review study requirements Those not qualifying for the study or uninterested will be thanked for their initial interest If the respondent is a viable prospect for inclusion the electronic medical record will be reviewed by the authorized research team member to verify inclusion criteria are satisfied and no exclusion criteria are present An initial study-related appointment coinciding with their next scheduled wound care appointment at the CHILE clinic will be set for eligible prospects After screening into the study the prospects will be randomly assigned to a group via an online randomizer Group 1 Treatment as Usual TAU participants receive the regularly scheduled standard wound care Group 2 Treatment as Usual plus Exercise TAU-EX receives the regularly scheduled standard wound care and is assigned to the 12 -week medically supervised exercise program Body mass index BMI HbA1c weight wearing similar clothes at each weigh in and vascular endothelial growth factor VEGF levels will be measured at baseline and then again at 4 8 and 12 weeks
The Informed Consent will be provided for the prospects review questions asked of the research team member are encouraged The 5050 likelihood of being randomly assigned to one of two groups TAU or TAU-EX will be explained All participants will receive their regularly scheduled standard wound care per CHILE Clinic procedures 2-3 times a week for 12 weeks or until the wound healed if less than 12 weeks Expectations of group assignment and incentivizing prospects for their time will be discussed fully If the prospect wants to continue with the study the Informed Consent will be signed If the prospect does not want to continue they will be thanked for their time plus encouraged to continue with their scheduled wound care appointments and follow their wound care professionals recommendations A Spanish interpreter in person or via phone will be used for all subjects who are not fluent in English Official Spanish language versions of the Consent Form and study questionnaires will be available as well Regardless of group assignment the participant will be reminded to continue with their normally scheduled wound care appointments and to follow their wound care professionals recommendations All participants will also be encouraged to maintain their normal daily activities unless contraindicated by their wound care provider A typical wound care appointment consists of the CHILE clinic wound care technician removing the dressing A wound care provider evaluates the drainage and the wound It is then cleaned with Vashe Steadme Medical Fort Worth TX The periwound is cleaned with Hibiclens Molnlycke Health Care Brooklyn NY If debridement is necessary it is performed by the wound care provider as appropriate for the tissue type and location Measurement of the wound will be done weekly by the wound care provider using one of two accepted wound measurement methods - clock method or modified clock method Deviations from the 1200 - 600 numbering scheme are documented for length ie 200 - 800 and width at the widest perpendicular ie 1000 - 500 point to the line of length Wound depth will be measured at the deepest section and any undermining or tunneling will be referred to by the clock measures New dressings will be applied
After giving written consent the TAU-EX participant will be scheduled for an initial intake session at the UNM Cardiac Rehabilitation facility ground floor of UNM hospital UNMH to review risk factors current exercise habits exercise session expectations and undergo a program orientation They will sign a second consent form be given a tour of the facility and familiarized with the exercise equipment They will be reminded that they will be exercising along with cardiac rehabilitation clients in 2 to 3 exercise sessions per week the sessions will ideally coincide with the TAU-EX participants normally scheduled wound care appointments An appointment will be scheduled so the Cardiac Rehabilitation staff can conduct a maximal exercise capacity test per the facilitys standard procedure note arm-ergometry will be used the heart rate HR blood pressure BP rating of perceived exertion RPE arm cranking cadence and intensity will be converted to MET metabolic equivalent of task levels with peak MET MET peak being the basis for each individualized exercise prescription Systematic program progression is supervised by the cardiac rehabilitation program staff Exercise program adjustments to intensity duration and modality will be made each session as appropriate and as tolerated by the participant Exercise-related variables ie intensity duration and modality will be recorded each session HR and oxygen saturation O2 sat will be recorded pre- during and post exercise Blood pressure and non-fasting blood glucose will be recorded pre- and post-exercise
The first exercise session begins with a pre-participation non-fasting blood glucose finger stick resting HR and BP assessments a brief eg 5-minute warm-up on an arm ergometer and a consult regarding session goals The exercise physiologist will encourage the participant to exercise in timed bouts at the combination of cadence and resistance equivalent to 50 of MET peak Each bout is followed by a recovery period low speed cadence very light resistance until HR approaches the pre-exercise level This is followed by iterations of exertion and active recovery until 20-30 minutes have passed Following the last bouts active recovery period and seated rest for hemodynamic assessment the exercise physiologist records all session data comments observations and reviews the session with the participant before scheduling the next exercise session All subsequent exercise sessions begin with a pre-participation finger stick blood glucose target range is 100-250 mgdL resting hemodynamic assessment brief warm-up and consult Together the exercise physiologist and participant set new goals for the days session ie increase cadence by 10 rpm at same resistance exercise at the RPE associated with a slightly higher intensity add 20 seconds to the exercise bout for the session etc The participants physiological responses are monitored to ensure safety and recorded for use in upcoming sessions Exercise prescriptions will be progressed based on individual tolerance adaptation and motivation
Standard wound care appointments consist of removal of wound dressing evaluation of wound eg drainage tissue status wound cleaning debridement as necessary measurement redressing and offloading eg total contact casting as applicable Over the 12-wk intervention period all participants will be instructed to continue their normal daily routines and adherence to the podiatrists recommendations The blood glucose range of 100-250 mgdL is the acceptable range for the participant to be able to begin the days exercise program If the glucose is above or below that range and the participant is symptomatic the clinic staff will contact the designated research team member who will contact the participants primary care provider and either refer them to their services or direct the staff to take them to the UNM Urgent Care Clinic If the participant is asymptomic the clinic staff will contact the designated research team member and she will discuss the options with the participant regarding going home and re-adjusting meals medication or whatever seemed to be the problem and have the participant return to exercise in 1-2 days
Volunteers may withhold participation or withdraw from the study at any time without impact on their DFU wound care at the CHILE clinic coverage of TAU-EX exercise sessions will cease Participants may be withdrawn from the study by research team members if instructions are repeatedly ignored or the participant is deemed at risk for harming themselves if they continue Upon withdrawal from the study any hard copy information will be placed in a locked medical records bin that is destroyed in accordance with UNM hospital regulations for destroying all patient information Data collected prior to withdrawal will remain in the study database and may not be removed until 6 years after the study is completed
As with any type of exercise there are risks of injury loss of consciousness heart attack and death Unaccustomed increases in HR breathing rate and sweating during exercise sessions self-consciousness when exercising in a small group and muscle soreness are all normal responses to exercise Development of an infection may or may not be associated with the exercise program All in the TAU-EX group will have provided documentation indicating their medical provider approved of their participation TAU-EX members will be counseled regarding the warning signs and symptoms of heart attacks shortness of breath andor loss of consciousness
All exercise sessions will be supervised by the exercise physiologists of the UNMH cardiac rehabilitation program symptoms indicative of cardiometabolic distress will result in stoppage or intensity reduction of the exercise session Participants in the TAU and TAU-EX groups may experience bruising soreness bleeding fainting as a result of blood draws and discomfort resulting from the wound care appointments Finger sticks for the TAU-EX group may result in localized discomfort andor bruising DFU wound care is part of each participants normal treatment plan and beyond the scope of this study
There may be no direct benefit for individuals participating in this study However some people have experienced weight loss improved blood glucose control and faster wound healing when exercising on a regular basis On a larger scale results from this study may inform the treatment plan of individuals receiving medical care for DFUs
Based on the nature of the research and the data that will collected The investigators may find that adherence to the wound care appointment schedules are increased for those in the TAU-EX group compared to TAU The investigators may also find that adherence may be predicted based on some of the response combinations recorded on the questionnaires ie support of partner transportation comradery developed during exercise sessions
A research team member collects box contents M-F and contacts all respondents using the preferred method provided on the RSVP to conduct an initial screening of inclusionexclusion criteria and review study requirements Those not qualifying for the study or uninterested will be thanked for their initial interest If the respondent is a viable prospect for inclusion the electronic medical record will be reviewed by the authorized research team member to verify inclusion criteria are satisfied and no exclusion criteria are present An initial study-related appointment coinciding with their next scheduled wound care appointment at the CHILE clinic will be set for eligible prospects After screening into the study the prospects will be randomly assigned to a group via an online randomizer Group 1 Treatment as Usual TAU participants receive the regularly scheduled standard wound care Group 2 Treatment as Usual plus Exercise TAU-EX receives the regularly scheduled standard wound care and is assigned to the 12 -week medically supervised exercise program Body mass index BMI HbA1c weight wearing similar clothes at each weigh in and vascular endothelial growth factor VEGF levels will be measured at baseline and then again at 4 8 and 12 weeks
The Informed Consent will be provided for the prospects review questions asked of the research team member are encouraged The 5050 likelihood of being randomly assigned to one of two groups TAU or TAU-EX will be explained All participants will receive their regularly scheduled standard wound care per CHILE Clinic procedures 2-3 times a week for 12 weeks or until the wound healed if less than 12 weeks Expectations of group assignment and incentivizing prospects for their time will be discussed fully If the prospect wants to continue with the study the Informed Consent will be signed If the prospect does not want to continue they will be thanked for their time plus encouraged to continue with their scheduled wound care appointments and follow their wound care professionals recommendations A Spanish interpreter in person or via phone will be used for all subjects who are not fluent in English Official Spanish language versions of the Consent Form and study questionnaires will be available as well Regardless of group assignment the participant will be reminded to continue with their normally scheduled wound care appointments and to follow their wound care professionals recommendations All participants will also be encouraged to maintain their normal daily activities unless contraindicated by their wound care provider A typical wound care appointment consists of the CHILE clinic wound care technician removing the dressing A wound care provider evaluates the drainage and the wound It is then cleaned with Vashe Steadme Medical Fort Worth TX The periwound is cleaned with Hibiclens Molnlycke Health Care Brooklyn NY If debridement is necessary it is performed by the wound care provider as appropriate for the tissue type and location Measurement of the wound will be done weekly by the wound care provider using one of two accepted wound measurement methods - clock method or modified clock method Deviations from the 1200 - 600 numbering scheme are documented for length ie 200 - 800 and width at the widest perpendicular ie 1000 - 500 point to the line of length Wound depth will be measured at the deepest section and any undermining or tunneling will be referred to by the clock measures New dressings will be applied
After giving written consent the TAU-EX participant will be scheduled for an initial intake session at the UNM Cardiac Rehabilitation facility ground floor of UNM hospital UNMH to review risk factors current exercise habits exercise session expectations and undergo a program orientation They will sign a second consent form be given a tour of the facility and familiarized with the exercise equipment They will be reminded that they will be exercising along with cardiac rehabilitation clients in 2 to 3 exercise sessions per week the sessions will ideally coincide with the TAU-EX participants normally scheduled wound care appointments An appointment will be scheduled so the Cardiac Rehabilitation staff can conduct a maximal exercise capacity test per the facilitys standard procedure note arm-ergometry will be used the heart rate HR blood pressure BP rating of perceived exertion RPE arm cranking cadence and intensity will be converted to MET metabolic equivalent of task levels with peak MET MET peak being the basis for each individualized exercise prescription Systematic program progression is supervised by the cardiac rehabilitation program staff Exercise program adjustments to intensity duration and modality will be made each session as appropriate and as tolerated by the participant Exercise-related variables ie intensity duration and modality will be recorded each session HR and oxygen saturation O2 sat will be recorded pre- during and post exercise Blood pressure and non-fasting blood glucose will be recorded pre- and post-exercise
The first exercise session begins with a pre-participation non-fasting blood glucose finger stick resting HR and BP assessments a brief eg 5-minute warm-up on an arm ergometer and a consult regarding session goals The exercise physiologist will encourage the participant to exercise in timed bouts at the combination of cadence and resistance equivalent to 50 of MET peak Each bout is followed by a recovery period low speed cadence very light resistance until HR approaches the pre-exercise level This is followed by iterations of exertion and active recovery until 20-30 minutes have passed Following the last bouts active recovery period and seated rest for hemodynamic assessment the exercise physiologist records all session data comments observations and reviews the session with the participant before scheduling the next exercise session All subsequent exercise sessions begin with a pre-participation finger stick blood glucose target range is 100-250 mgdL resting hemodynamic assessment brief warm-up and consult Together the exercise physiologist and participant set new goals for the days session ie increase cadence by 10 rpm at same resistance exercise at the RPE associated with a slightly higher intensity add 20 seconds to the exercise bout for the session etc The participants physiological responses are monitored to ensure safety and recorded for use in upcoming sessions Exercise prescriptions will be progressed based on individual tolerance adaptation and motivation
Standard wound care appointments consist of removal of wound dressing evaluation of wound eg drainage tissue status wound cleaning debridement as necessary measurement redressing and offloading eg total contact casting as applicable Over the 12-wk intervention period all participants will be instructed to continue their normal daily routines and adherence to the podiatrists recommendations The blood glucose range of 100-250 mgdL is the acceptable range for the participant to be able to begin the days exercise program If the glucose is above or below that range and the participant is symptomatic the clinic staff will contact the designated research team member who will contact the participants primary care provider and either refer them to their services or direct the staff to take them to the UNM Urgent Care Clinic If the participant is asymptomic the clinic staff will contact the designated research team member and she will discuss the options with the participant regarding going home and re-adjusting meals medication or whatever seemed to be the problem and have the participant return to exercise in 1-2 days
Volunteers may withhold participation or withdraw from the study at any time without impact on their DFU wound care at the CHILE clinic coverage of TAU-EX exercise sessions will cease Participants may be withdrawn from the study by research team members if instructions are repeatedly ignored or the participant is deemed at risk for harming themselves if they continue Upon withdrawal from the study any hard copy information will be placed in a locked medical records bin that is destroyed in accordance with UNM hospital regulations for destroying all patient information Data collected prior to withdrawal will remain in the study database and may not be removed until 6 years after the study is completed
As with any type of exercise there are risks of injury loss of consciousness heart attack and death Unaccustomed increases in HR breathing rate and sweating during exercise sessions self-consciousness when exercising in a small group and muscle soreness are all normal responses to exercise Development of an infection may or may not be associated with the exercise program All in the TAU-EX group will have provided documentation indicating their medical provider approved of their participation TAU-EX members will be counseled regarding the warning signs and symptoms of heart attacks shortness of breath andor loss of consciousness
All exercise sessions will be supervised by the exercise physiologists of the UNMH cardiac rehabilitation program symptoms indicative of cardiometabolic distress will result in stoppage or intensity reduction of the exercise session Participants in the TAU and TAU-EX groups may experience bruising soreness bleeding fainting as a result of blood draws and discomfort resulting from the wound care appointments Finger sticks for the TAU-EX group may result in localized discomfort andor bruising DFU wound care is part of each participants normal treatment plan and beyond the scope of this study
There may be no direct benefit for individuals participating in this study However some people have experienced weight loss improved blood glucose control and faster wound healing when exercising on a regular basis On a larger scale results from this study may inform the treatment plan of individuals receiving medical care for DFUs
Based on the nature of the research and the data that will collected The investigators may find that adherence to the wound care appointment schedules are increased for those in the TAU-EX group compared to TAU The investigators may also find that adherence may be predicted based on some of the response combinations recorded on the questionnaires ie support of partner transportation comradery developed during exercise sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None