Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds

Merakris Therapeutics

Status

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

Treatments: Drug: MTX-001 (Dermacyte Liquid)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06730022

DL-EAP-201

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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