Diabetic Foot Ulcer, Venous Leg Ulcer
Conditions
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 hard-to-heal diabetic foot and venous leg ulcers.
Detailed description
Hard to heal 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 hard to heal chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SC) treatment and frequently become infected. Advanced wound products like CAMPs have become an important strategy in the treatment of hard-to-heal chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing. The study will evaluate the clinical utility of Multiple CAMPs in the closure of hard to heal diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.
Interventions
DEVICEUrinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers
Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and 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.
DEVICEUrinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers
Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and 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.
DEVICEAmnioExcel Plus for Venous Leg Ulcers
Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and 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.
DEVICEAmnioExcel Plus for Diabetic Foot Ulcers
Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and 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.
PROCEDUREStandard of Care
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.
Sponsors
Integra LifeSciences Corporation
SerenaGroup, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
#1: Diabetic Foot Ulcers 1. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At Screening Visit 1 and at Randomization, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement. 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the malleolus. 7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: 1. ABI between 0.7 and 1.3; 2. TBI greater or equal to 0.6; 3. TCOM greater or equal to 40 mmHg; 4. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post debridement. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. 9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment. 10. The potential subject must consent to using the prescribed offloading method for the duration of the study. 11. The potential subject must agree to attend the weekly study visits required by the protocol. 12. The potential subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of complete wound closure for target ulcer | 1-12 weeks | The percentage of target ulcers, DFU and VLU, achieving complete wound closure Complete wound closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete wound closure for target ulcer | 1-12 weeks | Time to closure will be determined for each treatment group and compared to SOC |
| Percentage of wound area reduction for target ulcer | 1-12 weeks | Percent Area Reduction (PAR) will be calculated from measurements at Week 1 compared to measurements at week 12 |
| Adverse Events | 1-14 weeks | Incidence of adverse events will be evaluated weekly from the first study visit to the Closure Confirmation Visit (CCV). |
| Changes to pain associated with the target ulcer | 1-14 weeks | Change in target ulcer pain assessed weekly from the first study visit to the Closure Confirmation Visit (CCV), using a 0 to 10 Pain scale with 0 = "No Pain" and 10 = "Most Intense Pain Imaginable". |
| Determine improvement in Quality of Life | 1-14 weeks | Quality of Life assessed at the study randomization visit and the Closure Confirmation Visit (CCV), using a Minimal Important Difference (MID) of 0.50 based on the averaged overall score from 0 to 4 of all items the Wound Quality of Life (wQOL) checklist, with higher score indicating worse wQOL |
| Improvement of the Forgotten Wound Score (FWS) | 1-14 weeks | Forgotten Wound Score (FWS) assessed at the study randomization visit and the Closure Confirmation Visit (CCV) based a 0 to 100 scale with higher indicating a high degree of "forgetting" the wound |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTomas Serena, MD
SerenaGroup, Inc.
Outcome results
None listed