Feasibility Study of the Execution of an Efficacy Trial in the Nursing Home Setting
Primary Purpose
Partial Thickness Wounds
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Xenaderm® Ointment
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Partial Thickness Wounds focused on measuring Xenaderm, partial, thickness, wounds, Nursing Homes
Eligibility Criteria
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
- 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).
- 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:
- Have more than 64 cm2 of total denuded wound area, including target and non-target wounds.
- Have a full-thickness wound within 4 cm of any target wound.
- Have clinical evidence of bacterial or fungal infection of the target wound.
- 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).
- Are moribund, or has a severe burn, immunodeficiency disorder, hematologic disorder, metastatic malignancy or uncontrolled diabetes mellitus.
- Are known to have acrodermatitis enteropathica (zinc deficiency).
- Are being treated with systemic steroids, immunosuppressive agents, radiation or chemotherapy.
- Have been treated with enzymatic debridement to the target wound(s) within 2 days prior to enrollment.
- Have a known sensitivity to ingredients of Xenaderm Ointment.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Complete Wound Closure
Secondary Outcome Measures
Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00714519
Brief Title
Feasibility Study of the Execution of an Efficacy Trial in the Nursing Home Setting
Official Title
A Phase II Feasibility Study of Xenaderm® Ointment Exploring Design Issues for Phase III Efficacy in Partial-Thickness Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Withdrawn
Why Stopped
The study was terminated due to the inability to enroll subjects. No subjects were or ever will be enrolled into this study.
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Healthpoint
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess if a clinical trial regarding healing of partial thickness wounds can be executed in nursing homes.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Thickness Wounds
Keywords
Xenaderm, partial, thickness, wounds, Nursing Homes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xenaderm® Ointment
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Topical, BID or as needed
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Other Intervention Name(s)
Xenaderm® Ointment
Intervention Description
Topical, BID or as needed
Primary Outcome Measure Information:
Title
Complete Wound Closure
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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).
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:
Have more than 64 cm2 of total denuded wound area, including target and non-target wounds.
Have a full-thickness wound within 4 cm of any target wound.
Have clinical evidence of bacterial or fungal infection of the target wound.
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).
Are moribund, or has a severe burn, immunodeficiency disorder, hematologic disorder, metastatic malignancy or uncontrolled diabetes mellitus.
Are known to have acrodermatitis enteropathica (zinc deficiency).
Are being treated with systemic steroids, immunosuppressive agents, radiation or chemotherapy.
Have been treated with enzymatic debridement to the target wound(s) within 2 days prior to enrollment.
Have a known sensitivity to ingredients of Xenaderm Ointment.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Healthpoint
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Innes Cargill, PhD
Organizational Affiliation
Healthpoint
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of the Execution of an Efficacy Trial in the Nursing Home Setting
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