Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.

Conditions

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer, Diabetic
• Leg Ulcer
• Ulcer
• Ulcer Foot
• Ulcer Venous
• Venous Leg
• Venous Leg Ulcer

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ACApatch™ — OTHER
  Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
• caregraFT™ — OTHER
  Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
• Standard of Care — OTHER
  Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Study Details

Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.

Key Dates

Start date

Dec 6, 2024

Status verified

Feb 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

340 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: DFU CAMP 1 + SOC = ACApatch™ + SOC
  ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue.
• Experimental: DFU CAMP 2 + SOC = caregraFT™ + SOC
  caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue.
• Active Comparator: DFU Standard of Care
  Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.
• Experimental: VLU CAMP 1 + SOC = ACApatch™ + SOC
  ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue.
• Experimental: VLU CAMP 2 + SOC = caregraFT™ + SOC
  caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue.
• Active Comparator: VLU Standard of Care
  Standard of care will be cleaning, debridement, and ulcer moisture balance.

Primary Outcome Measure

The between-arm difference in subjects that complete wound closure [ Time Frame: 1-12 Weeks ]

Central Contacts

• Arshdeep Kaur, MS
  1-888-665-5005
  [email protected]
• Madison Dunn
  [email protected]

Locations (1)

Find similar trials in Monroeville, PA

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