Burns - Multiple, Cutaneous Ulcer, Diabetic Ulcer, Ischemic Ulcer, Mixed Ulcer, Pressure Ulcers, Surgical Wound Dehiscence
Conditions
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.
Interventions
DRUGMTX-001 (Dermacyte Liquid)
Repeat dose subcutaneous drug injection for the treatment of serious chronic wounds.
Sponsors
Merakris Therapeutics
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Contacts
Primary ContactSean O'Connell, PhD Scientic & Medical Affairs Scientist
Outcome results
None listed