Developing a Diabetic Foot Ulcer Protocol

Developing a Diabetic Foot Ulcer Protocol in a Multi-ethnic, Underserved Population

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Other: type of footwear; Other: collagen dressing with and without silver

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • Harris County Hospital District Community Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
decrease in size of wound	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
non-healing wound	6 months or less

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 11, 2010
• First Submitted That Met QC Criteria: February 11, 2010
• First Posted (Estimate): February 12, 2010

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: diabetes; foot ulcers; off-loading; collagen; Wagner 1
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: HSC-GEN-09-0418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No