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

This study has been terminated.
(Expired study materials; low subject recruitment)
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01013792
First received: November 13, 2009
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention
Foot Ulcer, Diabetic
Device: Wound Dressing

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • Diabetic Foot Ulcer(DFU)Wound Healing [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: November 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-adherent Wound Dressing Device: Wound Dressing
Acetate mesh carrier with ointment (water, PEGs)
Active Comparator: Tegaderm Matrix Dressing with PHI technology Device: Wound Dressing
Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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?
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013792

Locations
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
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Joseph V Boykin, MD HCA Retreat Hospital
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01013792     History of Changes
Other Study ID Numbers: 05-011091
Study First Received: November 13, 2009
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 3M:
Diabetic
Foot
Ulcer
Neuropathic
Tegaderm Matrix Dressing
DFU
Wound Care
PHI

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on April 22, 2014