Feasibility Study of the Execution of an Efficacy Trial in the Nursing Home Setting
NCT ID: NCT00714519
Last Updated: 2013-08-30
Study Results
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2008-07-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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1
Xenaderm® Ointment
Topical, BID or as needed
2
Placebo Comparator
Topical, BID or as needed
Interventions
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Xenaderm® Ointment
Topical, BID or as needed
Placebo Comparator
Topical, BID or as needed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Are at least 18 years of age.
3. Are expected to remain in the Nursing Home for the duration of the study (22 days).
4. 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
* have been present for at least 2 days but less than 6 weeks;
* measure greater than or equal to 2 and less than or equal to40 cm2 in total denuded area; and,
* are connected by areas of erythema (for multiple wounds).
5. Are capable of maintaining an adequate nutritional intake during the study.
6. 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
2. Have a full-thickness wound within 4 cm of any target wound.
3. Have clinical evidence of bacterial or fungal infection of the target wound.
4. Have target wound(s) that involves tunneling, sinus tracks, shear injury, arterial occlusive disease or bony prominence or joint with the exception that target wounds may be over dorsal spinous processes, coccyx, ischial tuberosities or sacroiliac joints (but may not be full thickness).
5. Are moribund, or has a severe burn, immunodeficiency disorder, hematologic disorder, metastatic malignancy or uncontrolled diabetes mellitus.
6. Are known to have acrodermatitis enteropathica (zinc deficiency).
7. Are being treated with systemic steroids, immunosuppressive agents, radiation or chemotherapy.
8. Have been treated with enzymatic debridement to the target wound(s) within 2 days prior to enrollment.
9. Have a known sensitivity to ingredients of Xenaderm Ointment.
10. Are using or have used another investigational agent (not including devices such as hearing aids, pace makers, etc.) within 30 days prior to Visit 1.
18 Years
ALL
No
Sponsors
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Healthpoint
INDUSTRY
Responsible Party
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Healthpoint
Principal Investigators
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Herbert B Slade, MD
Role: STUDY_CHAIR
Healthpoint
Innes Cargill, PhD
Role: STUDY_DIRECTOR
Healthpoint
Countries
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Other Identifiers
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011-101-09-032
Identifier Type: -
Identifier Source: org_study_id