Evaluating new treatments for diabetic foot and venous leg ulcers

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 DFUs and VLUs.

This study is testing different new treatments for stubborn diabetic foot and leg ulcers to see if they help heal better than the standard care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 324 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Stability Biologics (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Circleville, Ohio)
• Trial ID: NCT06560502 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized controlled trial aims to assess the effectiveness of various cellular, acellular, and matrix-like products (CAMPs) in combination with standard of care (SOC) compared to SOC alone for treating nonhealing diabetic foot ulcers and venous leg ulcers. Participants will be monitored over a 12-week period to determine the proportion of subjects achieving complete ulcer closure. The study employs a modified dual platform design, allowing for the evaluation of multiple CAMPs tailored to each wound type. The initial plan includes five CAMPs per wound type, with flexibility for additional products as needed.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with type 1 or 2 diabetes and specific nonhealing ulcers on their feet.

Not a fit: Patients with ulcers not meeting the size, duration, or grade criteria, or those with inadequate limb perfusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve healing rates for patients with chronic diabetic foot and venous leg ulcers.

How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this trial.

Eligibility criteria

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.

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.

Where this trial is running

Circleville, Ohio

• Cutting Edge Research — Circleville, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Bennett M Rogers

Conditions Diabetic Foot Ulcer; Venous Leg Ulcer; Ulcer Foot; Leg Ulcer