Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Leg Ulcer; Ulcer Foot
• Interventions: Other: Standard of Care-DFU; Other: AmnioCore - DFU; Other: AmnioCore Pro; Other: Amnio Quad-Core - DFU; Other: Amnio Tri-Core - VLU; Other: Amniocore Pro +; Other: Standard of Care-VLU

• Registration Number: NCT06560502
• Lead Sponsor: Stability Biologics

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.

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

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 .

  2. 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.

  3. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.

  4. 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.

  5. 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.

Exclusion Criteria

1. The potential subject is known to have a life expectancy of < 6 months.
2. The potential subject's target ulcer is not secondary to diabetes.
3. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. There is evidence of osteomyelitis complicating the target ulcer.
6. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
7. The potential subject is taking hydroxyurea .
8. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
9. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
10. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
11. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
12. The surface area measurement of the Target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
13. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
14. Women who are pregnant or considering becoming pregnant within the next 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care-DFU	Standard of Care-DFU	Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Off-loading using the off-loading boot or total contact cast (TCC) provided by SerenaGroup.
AmnioCore - DFU	AmnioCore - DFU	Dual layer, amniotic membrane allograft.
AmnioCore Pro - VLU	AmnioCore Pro	Three layer, amnion/chorion/amnion membrane allograft.
Amnio Quad-Core - DFU	Amnio Quad-Core - DFU	Four layer, amniotic membrane allograft.
Amnio Tri-Core - VLU	Amnio Tri-Core - VLU	Three layer, amniotic membrane allograft.
Amniocore Pro + - DFU	Amniocore Pro +	Dual layer, amnion/chorion membrane allograft.
Standard of Care-VLU	Standard of Care-VLU	Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Compression using multilayer compression wraps provided by SerenaGroup.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Cutting Edge Research; 🇺🇸 Circleville, Ohio, United States