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NCT00007280 · ClinicalTrials.gov registry record · Phase 1
Bioengineered Skin and Wound Healing
A Phase 1 study of Leg Ulcers, sponsored by Roger Williams Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00007280 is a Phase 1 study of Leg Ulcers that has completed, run by Roger Williams Medical Center. The registered enrollment target is 50 participants, above the 38-participant average among 3 other Leg Ulcers trials with a reported enrollment target (32% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00007280, a Phase 1 study of Leg Ulcers, has completed, sponsored by Roger Williams Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will look at whether a graft of bioengineered skin (BSC), known commercially as Apligraf, stimulates the healing process in a person's own skin at the edge of a wound (known as the edge effect). The information from this study will provide a better understanding of the ways that grafts of bioengineered skin help the healing of chronic wounds. We will assign study participants to either the bioengineered skin group or the control group. People in the control group will receive compression therapy with a multilayered compression bandage. We will examine each participant before starting treatment and then once a week for 24 weeks or until the wound heals. On the first day of treatment (day 0) and at week 3, week 6, and week 24 (end of treatment) we will take a small tissue sample from the wound for a biopsy. After the wound is completely healed, we will ask the patient to return once a month for 6 months to make sure the wound stays healed.
Conditions Studied
Interventions
- DEVICE Bioengineered skin
Study Locations (1)
Rhode Island
- Roger Williams Medical Center Dept. of Dermatology & Skin Surgery - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2000-10 |
| Est. Completion | 2005-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00007280
The ClinicalTrials.gov registry entry for NCT00007280 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 38-participant average among 3 other Leg Ulcers trials with a reported enrollment target (32% higher). The listed sponsor is Roger Williams Medical Center, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Leg Ulcers appearing as the primary indexed condition, and to 1 intervention - of which Bioengineered skin is the first listed.
NCT00007280 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT00007280 about?
NCT00007280 is a clinical study titled "Bioengineered Skin and Wound Healing". This study will look at whether a graft of bioengineered skin (BSC), known commercially as Apligraf, stimulates the healing process in a person's own skin at the edge of a wound (known as the edge effect). The information from this study will provide a better understanding of the ways that grafts of...
What is the current status of trial NCT00007280?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2000-10. Estimated completion is 2005-08.
What conditions does trial NCT00007280 study?
This clinical trial studies the following conditions: Leg Ulcers.
What interventions are being tested in trial NCT00007280?
The interventions under investigation include: Bioengineered skin (DEVICE).
Who is sponsoring clinical trial NCT00007280?
This trial is sponsored by Roger Williams Medical Center, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00007280 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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