A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Foot Ulcer, Diabetic Clinical Trial

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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

1. 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.

2. 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

1. To measure and compare the incidence of adverse events experienced by subjects in each of the 2 treatment groups.

2. To measure and compare the wound characteristics of each treatment group.

3. To measure and compare the subjects' quality of life of each treatment group.

4. To measure and compare the cost effectiveness of each treatment group.

5. 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.

6. 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.

7. 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

• NCT number: NCT01013792
• Study type: Interventional
• Source: 3M
• Status: Terminated
• Phase: N/A
• Start date: November 2009
• Completion date: July 2012