Clinical trial NCT01068171: Developing a Diabetic Foot Ulcer Protocol
Official title: Developing a Diabetic Foot Ulcer Protocol in a Multi-ethnic, Underserved Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: diabetes
foot ulcers
off-loading
collagen
Wagner 1
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Harris County Hospital District
name: Baylor College of Medicine
First posted: 2010-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: decrease in size of wound
timeFrame: 6 months
Secondary outcomes:
measure: non-healing wound
timeFrame: 6 months or less
Other outcomes:
Locations:
city: Houston
country: United States
facility: Harris County Hospital District Community Health
state: Texas
Study officials:
affiliation: University of Texas Health Science at Houston, Baylor College of Medicine
name: Gary Lepow, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Harris County Hospital District
name: Talar L Glover, MS, RN, CNS
role: PRINCIPAL_INVESTIGATOR
References: