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Developing a Diabetic Foot Ulcer Protocol

The University of Texas System (UT) logo

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Withdrawn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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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