Study of New Treatments for Nonhealing Diabetic Foot Ulcers
This study is looking for people aged 18 and older with nonhealing diabetic foot ulcers (sores on the foot due to diabetes) to test several new treatments. These treatments are called Activate™ Matrix, AmnioDefend™ FT Matrix, Palisade™ DM Matrix, Enclose™ TL Matrix, and Sentry™ SL Matrix. Each treatment will be applied weekly along with standard care for up to 12 weeks, or until the ulcer closes. The main goal is to see which treatment helps the ulcers close completely. You would need to have a diabetic foot ulcer between 1.0 cm² and 15.0 cm² in size. The study is currently recruiting about 350 participants.
- Study design
- This is a randomized controlled clinical trial, meaning participants are assigned by chance to one of the treatment groups. The study aims to enroll 350 participants.
- What's involved
- Participants will receive weekly applications of one of the study treatments and standard care for up to 12 weeks, or until their ulcer closes.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome of complete ulcer closure is measured between 1 and 12 weeks.
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NCT07086443
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
Recruiting
PHASE4Ages 18+InterventionalTreatmentSequence LifeScience, Inc.
~350 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Activate™ MatrixAmnioDefend™ FT MatrixPalisade™ DM MatrixEnclose™ TL MatrixSentry™ SL MatrixShelter™ DM Matrix + SOC
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Between-arm difference in subjects achieving complete closure
Measured over 1-12 Weeks
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
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
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.
What this trial measures
- Between-arm difference in subjects achieving complete closure1-12 Weeks
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.