Loading clinical trials...

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

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

NCT07086443•Sequence LifeScience, Inc.

View on ClinicalTrials.gov

Summary

The goal of this study is 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.

Detailed Description

This study is a prospective modified platform multicenter randomized controlled clinical trial. The goal of this study is 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;

Exclusion Criteria

•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.
•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.
+14 more criteria

Locations (1)

Serena Group- Monroeville

Monroeville, Pennsylvania, United States

Key Dates

Start Date

July 11, 2025

Primary Completion Date

July 1, 2027

Completion Date

July 1, 2027

Last Updated

July 25, 2025

Enrollment

350

ESTIMATED participants

Conditions

Diabetic Foot UlcerDFUDiabetic Foot Ulcer (DFU)Foot Ulcer Due to Type 1 Diabetes MellitusFoot Ulcer Due to Type 2 Diabetes MellitusUlcerUlcer Foot

Interventions

Activate™ Matrix

OTHER

AmnioDefend™ FT Matrix

OTHER

Palisade™ DM Matrix

OTHER

Enclose™ TL Matrix

OTHER

Sentry™ SL Matrix

OTHER

Shelter™ DM Matrix + SOC

OTHER

Contacts

Bennett Sarver

CONTACT

888-960-1343 bsarver@serenagroups.com

Thomas Serena, MD

CONTACT

814-688-4000 tserena@serenagroups.com

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

NCT06821230

MindfulnessCaregivers+5 more

View study

RECRUITINGNA

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

NCT07039396

Diabetic Foot Ulcer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

Inclusion Criteria

Exclusion Criteria

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers

Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

Bedside Bone Biopsy in Diabetic Foot Osteomyelitis