Official Title: “A Multi-centered, Prospective, Randomized, Double-blinded, Comparison of an Investigational Non-adherent Dressing to a Commercial Wound Dressing in the Management of Non-healing Diabetic Foot Ulcers”

The primary objective is to: - Assess the effect of the study dressings 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 commercial dressing. - Assess the costs of using the investigational dressing compared to the commercial dressing. - 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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

Study Primary Completion Date: December 2011

Intervention(s) in this Clinical Trial

• Device: Wound Dressing
  • Acetate mesh carrier with ointment (water, PEGs)
• Device: Wound Dressing
  • Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Non-adherent Wound Dressing
• Active Comparator: Tegaderm Matrix Dressing

Primary Measures

• Wound healing
  • Time Frame: 25 weeks
    Safety Issue?: No

Secondary Measures

• Incidence of adverse events
  • Time Frame: 25 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Is the subject 18 years of age or older?
• 2. Does the subject have a chronic full thickness diabetic foot ulcer (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 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?

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: 3M

Overall Clinical Trial Officials and Contacts

Joseph V Boykin, MD Principal Investigator HCA Retreat Hospital  

Overall Contact: Central Contact 651-733-9462 

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01013792

Study ID Number: 05-011091

ClinicalTrials.gov Identifier: NCT01013792

Health Authority: United States: Institutional Review Board