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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTX-001 (Dermacyte Liquid) | Drug | Repeat dose subcutaneous drug injection for the treatment of serious chronic wounds. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean O'Connell, PhD Scientic & Medical Affairs Scientist | Contact | 973-214-0837 | seano@merakris.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The WISH Clinic | Available | Arvada | Colorado | 80004 | United States |
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| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D013529 | Surgical Wound Dehiscence |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| D013568 | Pathological Conditions, Signs and Symptoms |