Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

NCT07086443 | Recruiting Phase 4

• 1 other identifier: RENEW
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer; DFU; Diabetic Foot Ulcer (DFU); Foot Ulcer Due to Type 1 Diabetes Mellitus; Foot Ulcer Due to Type 2 Diabetes Mellitus; Ulcer; Ulcer Foot

Outcome Measures

Primary Outcomes (1)

• Between-arm difference in subjects achieving complete closure

  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.

  1-12 Weeks

Secondary Outcomes (5)

• Time to closure

  1-12 weeks

• Percentage area reduction rate

  1-12 weeks

• Adverse Events

  1-12 Weeks

• Determine quality of life

  1-12 weeks

• Determine Quality of Life

  1-12 weeks

Study Arms (6)

Activate™ Matrix +SOC

EXPERIMENTAL

Three layers: amnion, intermediate layer, and chorion

Other: Activate™ Matrix

AmnioDefend™ FT Matrix +SOC

EXPERIMENTAL

Three layers: amnion, intermediate layer, and chorion

Other: AmnioDefend™ FT Matrix

Palisade™ DM Matrix +SOC

EXPERIMENTAL

Two layers: amnion and chorion

Other: Palisade™ DM Matrix

Enclose™ TL Matrix +SOC

EXPERIMENTAL

Three layers: amnion, chorion, amnion

Other: Enclose™ TL Matrix

Sentry™ SL Matrix +SOC

EXPERIMENTAL

One layer: amnion

Other: Sentry™ SL Matrix

Shelter™ DM Matrix +SOC

EXPERIMENTAL

Two layers: amnion and chorion

Other: Shelter™ DM Matrix + SOC

Interventions

Activate™ Matrix OTHER

Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Activate™ Matrix +SOC

AmnioDefend™ FT Matrix OTHER

Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

AmnioDefend™ FT Matrix +SOC

Palisade™ DM Matrix OTHER

Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Palisade™ DM Matrix +SOC

Enclose™ TL Matrix OTHER

Participants will receive weekly applications of Enclose™ TL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Enclose™ TL Matrix +SOC

Sentry™ SL Matrix OTHER

Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Sentry™ SL Matrix +SOC

Shelter™ DM Matrix + SOC OTHER

Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Shelter™ DM Matrix +SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Sequence LifeScience, Inc.: lead
• Serena Group: collaborator

Study Sites (1)

Serena Group- Monroeville

Monroeville, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Ulcer; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foot Diseases

Central Study Contacts

Bennett Sarver

CONTACT

888-960-1343; bsarver@serenagroups.com

Thomas Serena, MD

CONTACT

814-688-4000; tserena@serenagroups.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a multi-center, prospective, matched control clinical study trial evaluating placental derived allografts and standard of care versus standard of care alone in the treatment of nonhealing diabetic foot ulcers. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of seven CAMPs plus SOC for 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only the secondary dressing in the CAMP arm. The study utilizes a modified platform design adopted from clinical trials developed during the pandemic to simultaneously test multiple interventions in a single trial.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 25, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)