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The purpose of this study is to investigate the efficacy and safety of dehydrated amnion/chorion membrane (dHACM) in the treatment of patients with stage II or III pressure ulcer and decubitus ulcers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dHACM | Experimental | Standard of Care plus Weekly Application of dHACM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dHACM | Procedure | Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with complete wound closure of study ulcer | The percentage of subjects with complete wound closure of the study ulcer | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing kinetics: Complete wound healing | Total time for complete wound healing | 8 weeks |
| Wound healing kinetics: Weekly percentage of wounds with total closure | Percentage of wounds with total closure at each weekly visit time point |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Quality of Life for subjects [Exploratory] | Comparison of Quality of Life for subjects after treatment; This data will be measured by the SF-12 Health Survey at three time points throughout the study (8 weeks): prior to treatment, at 4 weeks, and at the end of the trial. | 8 weeks |
Inclusion Criteria:
Index ulcer characteristics:
Subject criteria must include:
Exclusion Criteria:
Index ulcer characteristics that will make subject ineligible for enrollment:
Subject criteria that will make subject ineligible for enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| David Mason, MD | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Specialists of Atlanta, PC | Decatur | Georgia | 30033 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 8 weeks |
| Wound healing kinetics: rate of closure/week | Rate of wound closure/week | 8 weeks |
| Incidence of Treatment-Emergent Adverse Events [Safety] | The endpoints for safety will be reported as the frequencies of occurrence of each adverse event, the rate of adverse events per patient/month and time to each event; Both serious and non-serious adverse events will be recorded | 8 weeks |
| Wound Infection Rate [Safety] | Additionally, wound infection rates will be noted throughout the course of the study | 8 weeks |