Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Interventions

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MTX-001 (Dermacyte Liquid)

Repeat dose subcutaneous drug injection for the treatment of serious chronic wounds.

Intervention Type DRUG

Eligibility Criteria

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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