Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
- Conditions
- Diabetic Foot UlcerVenous Leg Ulcer
- Interventions
- Other: Amnion-Intermediate-ChorionOther: Amnion-Chorion-AmnionProcedure: Standard of Care
- Registration Number
- NCT06562296
- Lead Sponsor
- Cellution Biologics
- Brief Summary
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers.
- Detailed Description
Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SOC) treatment and frequently become infected.
Advanced wound products like CAMPs have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.
This study will evaluate the clinical utility of Multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 292
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AIC for DFUs Amnion-Intermediate-Chorion Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. AIC for VLUs Standard of Care Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion sheet, a dehydrated multilayer human placental product derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. ACA for VLUs Amnion-Chorion-Amnion Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Chorion-Amnion allograft sheet, a dehydrated trilayer human placental product derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. ACA for VLUs Standard of Care Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Chorion-Amnion allograft sheet, a dehydrated trilayer human placental product derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. AIC for DFUs Standard of Care Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. AIC for VLUs Amnion-Intermediate-Chorion Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion sheet, a dehydrated multilayer human placental product derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. Standard of Care Standard of Care Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. ACA for DFUs Amnion-Chorion-Amnion Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Chorion-Amnion sheet allograft product, a dehydrated trilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. ACA for DFUs Standard of Care Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Chorion-Amnion sheet allograft product, a dehydrated trilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
- Primary Outcome Measures
Name Time Method Percentage of ulcers with complete wound closure 1-12 weeks The percentage of DFU and VLU target ulcers achieving complete wound closure. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.
- Secondary Outcome Measures
Name Time Method Percentage of wound area change for target ulcer 1-12 weeks Percentage wound area changes from week 1 to week 12 will be calculated weekly from measurements with digital photographic planimetry and physical examination.
Time to complete closure for ulcer 1-12 weeks Time to closure will be determined for each treatment group and compared to Standard Of Care. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.
Changes to pain associated with the target ulcer 1-12 weeks Change in pain in the target ulcer assessed using the Visual Analog Scale (VAS) from week 1 to week 12. VAS is a tool that uses a 0-10 (no to extreme pain) point scale to measure pain intensity.
Incidence of Adverse events 1-12 weeks The incidence of adverse events will be evaluated weekly from the first study visit to wound healing and/or final visit.
Determine changes in Quality of Life 1-12 weeks Changes in quality of life using both the Wound Quality of Life (wQOL) and Forgotten Wound Score (FWS) questionnaires that measure the health-related quality of life (HRQoL) of patients with chronic wounds.
wQOL questionnaire is scored using a 5-point Likert scale, where 0 means "not at all" and 4 means "very much". Higher scores indicate greater impairment of quality of life. Higher the score indicates lower quality of life. \[Time Frame: Visits 1, 4, 8, and 12/Final Visit\].
FWS questionnaire measures 12 activities scored 0-4. Responses are summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. Higher the score indicates lower quality of life. \[Time Frame: Visits 1, 4, 8, and 12/Final Visit\].
Trial Locations
- Locations (8)
Symphony Research
🇺🇸Jacksonville, Florida, United States
Santos Research Group
🇺🇸Tampa, Florida, United States
Magnolia Research
🇺🇸Lutcher, Louisiana, United States
Sure Step Foot & Ankle
🇺🇸Cincinnati, Ohio, United States
Ohio Foot & Ankle Specialists
🇺🇸Troy, Ohio, United States
Christus Wound Care
🇺🇸San Marcos, Texas, United States
RGV Wound Care Group
🇺🇸Weslaco, Texas, United States
Family Foot & Ankle
🇺🇸Kenosha, Wisconsin, United States