Wound matrix treatments for nonhealing diabetic foot ulcers

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls

This trial will test whether adding special wound matrix products to standard care helps close hard-to-heal diabetic foot ulcers in adults with type 1 or 2 diabetes within 12 weeks.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sequence LifeScience, Inc. (industry)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Monroeville, Pennsylvania)
• Trial ID: NCT07086443 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized, modified platform trial comparing multiple cellular and acellular matrix products plus standard of care to matched controls for nonhealing diabetic foot ulcers. Eligible adults have type 1 or 2 diabetes and a target ulcer 1.0–15.0 cm2 present at least 4 weeks that is largely below the malleolus and Wagner grade 1–2. Participants are randomized to receive one of several wound matrices (Activate™, AmnioDefend™ FT, Palisade™ DM, Enclose™ TL, Sentry™ SL) plus standard care or matched control treatment and followed for 12 weeks. The primary outcome is the proportion of ulcers achieving complete closure measured after debridement using imaging-based length-by-width assessment.

Who should consider this trial

Good fit: Adults (≥18) with type 1 or 2 diabetes who have a nonhealing foot ulcer 1.0–15.0 cm2 present at least 4 weeks, located mostly below the malleolus, Wagner grade 1–2, and with adequate limb perfusion.

Not a fit: Patients with exposed bone or tendon, poor limb perfusion, active uncontrolled infection, or ulcers outside the size/location criteria are unlikely to qualify or derive benefit from the tested interventions.

Why it matters

Potential benefit: If successful, this approach could increase complete wound closure rates and shorten healing time for patients with chronic diabetic foot ulcers, potentially reducing the need for further interventions.

How similar studies have performed: Previous trials of acellular and amniotic-derived wound matrices have shown mixed but often favorable results for diabetic foot ulcer healing, although direct head-to-head platform comparisons are limited.

Eligibility criteria

Inclusion Criteria:

* The potential subject must be at least 18 years of age or older.
* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width.
* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
* The potential subject must have a target ulcer that is 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. The ulcer may not include exposed tendon or bone.
* The potential subject's 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 ≥ 0.6;
  3. TCOM ≥ 40 mmHg;
  4. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
* The potential subject must have a target ulcer located on the 50% below the malleolus and not on the dorsal toes.
* The ulcer must be offloaded for at least 14 days prior to enrollment.
* The potential subject must consent to using the prescribed offloading method for the duration of the study.
* The potential subject must agree to attend the weekly study visits required by the protocol.
* The potential subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

* The potential subject is known to have a life expectancy of \< 6 months.
* The potential subject's target ulcer is not secondary to diabetes.
* The target ulcer is infected or there is cellulitis in the surrounding skin.
* The target ulcer exposes tendon or bone.
* There is evidence of osteomyelitis complicating the target ulcer.
* 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).
* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
* 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.
* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). 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).
* The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
* The potential subject has end stage renal disease requiring dialysis.
* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
* The potential subject has a malnutrition.
* The potential subject has a known allergy or sensitivity to PBS, IPA, processing solutions, reagents, or latex.

Where this trial is running

Monroeville, Pennsylvania

• Serena Group- Monroeville — Monroeville, Pennsylvania, United States (RECRUITING)

Study contacts

• Study coordinator: Bennett Sarver

Conditions: Diabetic Foot Ulcer, DFU, Foot Ulcer Due to Type 1 Diabetes Mellitus, Foot Ulcer Due to Type 2 Diabetes Mellitus, Ulcer, Ulcer Foot