Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study Details

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.

Key Dates

Start date

Jul 11, 2025

Status verified

May 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Activate™ Matrix +SOC
  Three layers: amnion, intermediate layer, and chorion
• Experimental: AmnioDefend™ FT Matrix +SOC
  Three layers: amnion, intermediate layer, and chorion
• Experimental: Palisade™ DM Matrix +SOC
  Two layers: amnion and chorion
• Experimental: Enclose™ TL Matrix +SOC
  Three layers: amnion, chorion, amnion
• Experimental: Sentry™ SL Matrix +SOC
  One layer: amnion
• Experimental: Shelter™ DM Matrix +SOC
  Two layers: amnion and chorion

Primary Outcome Measure

Between-arm difference in subjects achieving complete closure [ Time Frame: 1-12 Weeks ]

Central Contacts

• Bennett Sarver
  1-833-865-6300
  [email protected]
• Thomas Serena, MD
  1-833-865-6300
  [email protected]

Locations (1)

Find similar trials in Monroeville, PA

Related Studies

• A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
  Recruiting · Molnlycke Health Care AB · Castro Valley, California
• Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
  Recruiting · Piomic Medical · Mesa, Arizona
• DFC 004 Biomarkers for Active Diabetic Foot Ulcers
  Recruiting · University of Michigan · Tucson, Arizona
• Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
  Recruiting · StimLabs · Omaha, Nebraska