A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
The primary objective is to:
- Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
Secondary objectives are to:
- Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology.
- Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology.
- Assess and compare the impact that these dressings have on patients' quality of life.
- Assess the wound's biological response and pH to the study dressings.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multi-centered, Prospective, Randomized, Double-blinded, Comparison of an Investigational Non-adherent Dressing to 3M Tegaderm Matrix Dressing With PHI Technology in the Management of Non-healing Diabetic Foot Ulcers|
- Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as [(Baseline - Week 8)/Baseline] x 100%.
|Study Start Date:||November 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Non-adherent Wound Dressing
The non-adherent dressing is the same as the Tegaderm Matrix dressing, with potassium chloride, rubidium chloride, calcium chloride, zinc chloride, potassium citrate and citric acid removed. This dressing is a Class I medical device (21 CFR Sec. 878.4020 Occlusive wound dressing) that is exempt from premarket notification procedures.
Device: Wound Dressing
Acetate mesh carrier with ointment (water, PEGs)
Active Comparator: Tegaderm Matrix Dressing with PHI
A commercial wound dressing to be used per manufacturer's instructions for use.
Device: Wound Dressing
Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
The primary objective of this study is to compare the effect of an investigational, non-adherent dressing to a commercial wound dressing, 3M™ Tegaderm™ Matrix Dressing with PHI™ technology (Matrix dressing), in the management of diabetic foot ulcers. Subjects' wounds will be observed for a four week, pre-treatment period with wound assessments being made and samples of wound fluid and tissue collected and analyzed to characterize the wound. Following this pre-treatment observational stage, subjects continuing to meet inclusion/exclusion criteria will be randomly assigned, with stratification by center, wound size and wound duration, in either of two groups in the eight week treatment stage of the study. Subjects in one group will have their wound managed with an investigational non-adherent dressing, and subjects in the other group will have their wound managed with a Matrix dressing. At Visit 4 (start of the treatment stage of the study), subjects with a study wound that is less than 1 cm2 at this point will be dropped from the study. A second investigational device will be used to measure the pH of the wound, which will be compared to wound healing data.
Pre-treatment Stage Secondary Objectives
- To measure and compare changes in wound size and wound assessments with changes in wound biomarker levels, wound pH, microbial load, and changes in systemic levels of C-reactive protein and homocysteine.
- To measure and compare changes in wound biomarker levels, pH, and microbial load, and changes in systemic (blood) levels of C-reactive protein and homocysteine, looking for relationships.
Treatment Stage Secondary Objectives
- To measure and compare the incidence of adverse events experienced by subjects in each of the 2 treatment groups.
- To measure and compare the wound characteristics of each treatment group.
- To measure and compare the subjects' quality of life of each treatment group.
- To measure and compare the cost effectiveness of each treatment group.
- To measure and compare changes in wound size with changes in wound biomarker levels, pH, and microbial load; and changes in systemic (blood) levels of C-reactive protein and homocysteine.
- To measure and compare changes in wound biomarker levels, pH, microbial load, and changes in systemic levels of C-reactive protein and homocysteine, looking for relationships within treatment groups and overall.
- To assess the ease of using these dressing
Post-treatment Stage Secondary Objectives
Subjects whose wounds heal prior to Visit 12 are expected to have a follow-up appointment 12-14 weeks after their wound has healed. Subjects whose wounds do not heal by Visit 12 are expected to complete a follow-up appointment 12-14 weeks after their last appointment. The objectives of this are to determine the frequency of complete healing between the two treatment groups and to determine the number of wounds that had healed by the end of the treatment phase and remained healed for each group at the follow-up appointment.
The objective is to measure and compare the percentage of wounds healed by Visit 12 (or before) that remained healed at the follow-up appointment by treatment group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013792
|United States, Alabama|
|Terry Treadwell, MD|
|Montgomery, Alabama, United States, 36111|
|United States, California|
|Alex Reyzelman, DPM|
|Castro Valley, California, United States, 94546|
|United States, Florida|
|Wyatt Payne, MD|
|Bay Pines, Florida, United States, 33744|
|United States, Massachusetts|
|Vickie Driver, DPM|
|Boston, Massachusetts, United States, 02118|
|United States, North Carolina|
|William Marston, MD|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Virginia|
|Joseph Boykin, MD|
|Richmond, Virginia, United States, 23220|
|Principal Investigator:||Joseph V Boykin, MD||HCA Retreat Hospital|