Developing a Diabetic Foot Ulcer Protocol

The University of Texas System (UT)

Status: Withdrawn

Conditions: Diabetic Foot Ulcers

Treatments: Other: collagen dressing with and without silver; Other: type of footwear

Study type: Interventional

Funder types: Other

Identifiers

NCT01068171

HSC-GEN-09-0418

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 6 patient groups

shoe, plain dressing

Active Comparator group

Description:

post-op shoe with plain occlusive dressing

Treatment:

Other: type of footwear

shoe, collagen

Active Comparator group

Description:

post-op shoe with collagen dressing

Treatment:

Other: collagen dressing with and without silver

boot, plain dressing

Active Comparator group

Description:

air boot with occlusive dressing

Treatment:

Other: type of footwear

boot, collagen

Active Comparator group

Description:

air boot with collagen dressing

Treatment:

Other: collagen dressing with and without silver

monitored air boot, plain dressing

Active Comparator group

Description:

air boot with retention strap to monitor whether boot is removed with occlusive dressing

Treatment:

Other: type of footwear

monitored boot with collagen

Active Comparator group

Description:

air boot with retention strap to monitor whether boot is removed with collagen dressing

Treatment:

Other: collagen dressing with and without silver