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

NCT00714519 | Withdrawn Phase 2

• 1 other identifier: 011-101-09-032
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess if a clinical trial regarding healing of partial thickness wounds can be executed in nursing homes.

Conditions

Partial Thickness Wounds

Keywords

Xenaderm; partial; thickness; wounds; Nursing Homes

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  21 days

Secondary Outcomes (1)

• Adverse Events

  21 days

Study Arms (2)

1

EXPERIMENTAL

Drug: Xenaderm® Ointment

2

PLACEBO COMPARATOR

Drug: Placebo Comparator

Interventions

Xenaderm® Ointment DRUG

Topical, BID or as needed

Also known as: Placebo Comparator

1

Placebo Comparator DRUG

Topical, BID or as needed

Also known as: Xenaderm® Ointment

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthpoint: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

• Innes Cargill, PhD

  Healthpoint

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 30, 2013

Record last verified: 2013-08