Feasibility Study of the Execution of an Efficacy Trial in the Nursing Home Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714519
Recruitment Status : Withdrawn (The study was terminated due to the inability to enroll subjects. No subjects were or ever will be enrolled into this study.)
First Posted : July 14, 2008
Last Update Posted : August 30, 2013
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Brief Summary:
This study will assess if a clinical trial regarding healing of partial thickness wounds can be executed in nursing homes.

Condition or disease Intervention/treatment Phase
Partial Thickness Wounds Drug: Xenaderm® Ointment Drug: Placebo Comparator Phase 2

Detailed Description:
This study will test the efficacy of Xenaderm® vs. vehicle on the healing of partial thickness wounds caused by pressure, moisture and friction.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Feasibility Study of Xenaderm® Ointment Exploring Design Issues for Phase III Efficacy in Partial-Thickness Wounds
Study Start Date : July 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Xenaderm® Ointment
Topical, BID or as needed
Other Name: Placebo Comparator
Placebo Comparator: 2 Drug: Placebo Comparator
Topical, BID or as needed
Other Name: Xenaderm® Ointment

Primary Outcome Measures :
  1. Complete Wound Closure [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  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:

  1. Have more than 64 cm2 of total denuded wound area, including target and non-target wounds.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00714519

Sponsors and Collaborators
Study Chair: Herbert B Slade, MD Healthpoint
Study Director: Innes Cargill, PhD Healthpoint

Responsible Party: Herbert Slade, MD/Chief Medical Officer, Healthpoint Identifier: NCT00714519     History of Changes
Other Study ID Numbers: 011-101-09-032
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013

Keywords provided by Healthpoint:
Nursing Homes

Additional relevant MeSH terms:
Castor Oil
Gastrointestinal Agents