Diabetic Foot Ulcer, Leg Ulcer, Ulcer Foot, Venous Leg Ulcer
Conditions
Brief summary
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.
Detailed description
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design. \*The initial plan is to evaluate five CAMPs per wound type; however, the modified platform design permits the inclusion of additional CAMPs.
Interventions
OTHERStandard of Care-DFU
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 13 weeks, whichever occurs first.
OTHERAmnioCore - DFU
Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHERAmnio Quad-Core - DFU
Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHERStandard of Care-VLU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHERAmnio Tri-Core - VLU
Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHERAmnioCore Pro
Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHERAmniocore Pro +
Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Sponsors
SerenaGroup, Inc.
Stability Biologics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study design is a prospective modified dual platform (matriarch) multicenter randomized controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 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 medial aspect of 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: a. ABI between 0.7 and ≤ 1.3; b. TBI ≥ 0.6; c. TCOM ≥ 40 mmHg; d. 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 |
|---|---|---|
| Determine the between-arm difference | 1-12 Weeks | To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to closure | 1-12 Weeks | To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus SOC alone. |
| Percent Area Reduction | 1-12 weeks | To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus SOC alone. |
| Change in pain in target ulcer | 1-12 Weeks | To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4. |
| Adverse Events | 1-14 weeks | To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus SOC alone. |
| Determine improvement in Quality of Life - FWS and determine improvement in Quality of Life - wQOL | 1-12 weeks | To evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) and standard Wound Quality of Life (wQOL) questionnaires at treatment visits 1, 4, 8, and 12. |
Countries
United States
Contacts
Primary ContactBennett M Rogers
Backup ContactThomas Serena, MD
Outcome results
None listed