Developing a Diabetic Foot Ulcer Protocol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Harris County Hospital District
Baylor College of Medicine
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01068171
First received: February 11, 2010
Last updated: December 3, 2010
Last verified: December 2010
  Purpose

The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.


Condition Intervention
Diabetic Foot Ulcers
Other: type of footwear
Other: collagen dressing with and without silver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Developing a Diabetic Foot Ulcer Protocol in a Multi-ethnic, Underserved Population

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • decrease in size of wound [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • non-healing wound [ Time Frame: 6 months or less ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: shoe, plain dressing
post-op shoe with plain occlusive dressing
Other: type of footwear
comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored
Other Names:
  • DJO XP Diabetic Walker
  • Camcon Medical postoperative shoe
  • Smith and Nephew Allevyn Foam dressing
Active Comparator: shoe, collagen
post-op shoe with collagen dressing
Other: collagen dressing with and without silver
silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months
Other Names:
  • Smith & Nephew Biostep dressing with Allevyn Foam cover
  • Smith & Nephew Biostep Ag gressing with Allevyn Foam cover
Active Comparator: boot, plain dressing
air boot with occlusive dressing
Other: type of footwear
comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored
Other Names:
  • DJO XP Diabetic Walker
  • Camcon Medical postoperative shoe
  • Smith and Nephew Allevyn Foam dressing
Active Comparator: boot, collagen
air boot with collagen dressing
Other: collagen dressing with and without silver
silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months
Other Names:
  • Smith & Nephew Biostep dressing with Allevyn Foam cover
  • Smith & Nephew Biostep Ag gressing with Allevyn Foam cover
Active Comparator: monitored air boot, plain dressing
air boot with retention strap to monitor whether boot is removed with occlusive dressing
Other: type of footwear
comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored
Other Names:
  • DJO XP Diabetic Walker
  • Camcon Medical postoperative shoe
  • Smith and Nephew Allevyn Foam dressing
Active Comparator: monitored boot with collagen
air boot with retention strap to monitor whether boot is removed with collagen dressing
Other: collagen dressing with and without silver
silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months
Other Names:
  • Smith & Nephew Biostep dressing with Allevyn Foam cover
  • Smith & Nephew Biostep Ag gressing with Allevyn Foam cover

Detailed Description:

This pilot study will be conducted in Harris County Hospital District (HCHD) Community Health Centers and Wound Care Clinics.

The study will use random assignment of patients who meet inclusion criteria to: postoperative shoe with or without collagen; removable Air-boot with or without collagen; or monitored Air-boot with or without collagen. All treatment is standard of care.

Enrollment will occur at a clinic appointment. During the consent appointment, follow-up will be scheduled. Patients whose wound meets study criteria will be approached by a Podiatrist or therapist during a wound care visit. An A1c will be obtained, if not done within the past 3 months. A convenience sample will be drawn from people with diabetes, aged 18 or more, who meet inclusion criteria.

Frequency of visits will be:

  • patients with monitored Air-boot: weekly
  • all others: every 2 weeks At each visit there will be a dressing change, wound assessment and review of how many times shoe/boot was removed or not used during the preceding 1 or 2 weeks.

Should healing not occur within 6 months or the wound progress, the patient will be referred for evaluation of possible vascular involvement.

  Eligibility

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

Inclusion Criteria:

  • Adult - over 18 years of age
  • Diabetes with an A1c of less than or equal to 9% - if no A1c result is available within the past 3 months, one will be drawn to qualify the patient for the study
  • No evidence of circulatory compromise

    • Posterior tibial or pedal pulse present on palpation
    • No pallor on elevation
    • No dependent rubor
  • Loss of sensation on forefoot using monofilament
  • Wound or callus on only 1 foot
  • Wound Classification - Wagner Grade 1, non-infected

    • Ulcer present for 1 - 3 months
    • Ulcer of forefoot only
    • No previous ulcer of that foot or amputation of either extremity
    • Wound size < 1" diameter
    • Wound bed pink

Exclusion Criteria:

  • Diagnoses with unpredictable trajectory or healing ability, i.e.

    • Psychiatric disorders
    • Cancer
    • ESRD not eligible for dialysis
    • HIV
  • Previous lower extremity amputation
  • Charcot foot
  • Evidence of circulatory compromise

    • Absence of pulses
    • Decreased capillary refill (> 3 seconds)
    • Trophic skin changes - shiny, hairless toes
    • Ankle Brachial Index < 0.8
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068171

Contacts
Contact: Talar L Glover, MS, RN, CNS 713-566-2513 talar_glover@hchd.tmc.edu
Contact: Gary Lepow, DPM 713-790-0530 docgml@aol.com

Locations
United States, Texas
Harris County Hospital District Community Health Recruiting
Houston, Texas, United States, 77054
Contact: Talar L Glover, MS, RN, CNS    713-566-2513    talar_glover@hchd.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Harris County Hospital District
Baylor College of Medicine
Investigators
Principal Investigator: Gary Lepow, DPM University of Texas Health Science at Houston, Baylor College of Medicine
Principal Investigator: Talar L Glover, MS, RN, CNS Harris County Hospital District
  More Information

No publications provided

Responsible Party: Gary Lepow - Chief of Podiatry, UT Health Science Center - Houston and Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01068171     History of Changes
Other Study ID Numbers: HSC-GEN-09-0418
Study First Received: February 11, 2010
Last Updated: December 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
diabetes
foot ulcers
off-loading
collagen
Wagner 1

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 July 22, 2014