Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds

• Conditions: Cutaneous Ulcer; Diabetic Ulcer; Surgical Wound Dehiscence; Burns - Multiple; Pressure Ulcers; Mixed Ulcer; Ischemic Ulcer

• Registration Number: NCT06730022
• Lead Sponsor: Merakris Therapeutics

Brief Summary

The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid.

Detailed Description

The primary purpose is to provide expanded access of Dermacyte Liquid to subjects who have serious cutaneous ulcers and wounds (e.g., ulcers related to diabetes mellitus, venous insufficiency, complications of systemic sclerosis or rheumatic disease; decubitus ulcers, burns, acute trauma, wound dehiscence, ischemic ulcers, and mixed etiology ulcers). Eligible subjects must have a high likelihood of significant morbidity, loss of quality of life, potential amputation, or mortality without efficacious treatment. As there are many types of patients who may be enrolled, study results will not have statistical significance.

Study Timeline

• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Must be 18 years of age or older
• Must have a cutaneous ulcer or wound refractory to initial treatment or does not have an adequate treatment alternative, as determined by the Investigator

Exclusion Criteria

• Must not be pregnant or lactating
• Must not have known malignancies
• Must not be less than 18 years of age

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

The WISH Clinic; 🇺🇸 Arvada, Colorado, United States