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

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

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.

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.

Inclusion Criteria:

1. Is the subject 18 years of age or older?
2. Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks?
3. Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?
4. Does the subject show evidence of neuropathy?
5. Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis?
6. Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes?
7. Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)?
8. Is the subject willing to have photos taken of their wound and permit use of the photos in publications?
9. Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information?
10. Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8 - 1.2; or if the ABI is greater than 1.2, does the subject show toe pressures >40 mmHg, or transcutaneous oximetry (TcPO2) > 40 mm Hg, or does the subject show adequate circulation on an arterial Doppler study? (ABI or Doppler results must be < 45 days old.)
11. Is the subject able to comply with the protocol requirements?
12. If the subject is a woman of child bearing potential is she practicing an acceptable form of birth control as determined by the Investigator, and is she willing to have a pregnancy test?

Exclusion Criteria:

1. Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
2. Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?
3. Does the subject have an infection requiring systemic antibiotic treatment?
4. Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?
5. Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.)
6. Does the subject have Lupus or Crohn's disease?
7. Does the subject have an oxygen dependency?
8. Has the subject received hyperbaric oxygen therapy within the previous 90 days?
9. Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit?
10. Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?
11. Has the subject received Dermagraft®, Apligraf, or any other biologically active wound care product, or used Regranex Gel®, KGF, TGFβ or another topical growth factor to the study ulcer within the 30 days prior to the Screening visit?
12. Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents?
13. Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
14. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
15. Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit?