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The study was terminated due to the inability to enroll subjects. No subjects were or ever will be enrolled into this study.
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This study will assess if a clinical trial regarding healing of partial thickness wounds can be executed in nursing homes.
This study will test the efficacy of Xenaderm® vs. vehicle on the healing of partial thickness wounds caused by pressure, moisture and friction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenaderm® Ointment | Drug | Topical, BID or as needed |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Complete Wound Closure | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 21 days |
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Inclusion Criteria:
Provide written informed consent, which consists of reading, signing and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. If the subject is unable to read or sign the informed consent, or unable to comprehend the information provided in the consent process, a legal guardian, decision making proxy, or next of kin must provide written consent, and if possible, subject must verbally assent to receiving an experimental treatment for their wound.
Are at least 18 years of age.
Are expected to remain in the Nursing Home for the duration of the study (22 days).
Have one or more partial-thickness wounds (including wounds with excoriation, erosion or denuded skin, or ulceration to subcutaneous fat, but with no fascia, muscle, tendon or bone visible) on the trunk or proximal extremity (arm above the elbow, leg above the knee) which
Are capable of maintaining an adequate nutritional intake during the study.
Are in an acceptable state of health and nutrition with pre-albumin levels of greater than or equal to 15 mg/dl (0.015g/l), serum albumin greater than or equal to 3.0 g/dl (30g/l), alkaline phosphatase greater than or equal to the lower limit of normal, and have no abnormal laboratory values that, in the opinion of the Medical Supervisor, place the subject at risk for the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Healthpoint | Study Chair |
| Innes Cargill, PhD | Healthpoint | Study Director |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Placebo Comparator | Drug | Topical, BID or as needed |
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