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Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers

NCT06562296 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers.

Conditions

  • Venous Leg Ulcer
  • Diabetic Foot Ulcer

Interventions

OTHER

Amnion-Intermediate-Chorion

Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.

OTHER

Amnion-Chorion-Amnion

Dehydrated human placental trilayer allograft derived from donated human tissue.

PROCEDURE

Standard of Care

Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • LifeCell

    collaborator INDUSTRY

  • Cellution Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
98 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2025-06-11
Completion
2026-01-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06562296 on ClinicalTrials.gov