Developing a Diabetic Foot Ulcer Protocol

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01068171
• Other study ID #: HSC-GEN-09-0418
• Status: Withdrawn
• Phase: N/A
• Start date: May 2010
• Est. completion date: June 2012

Study information

• Verified date: November 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Harris County Hospital District Community Health	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Baylor College of Medicine, Harris County Hospital District

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in size of wound		6 months
Secondary	non-healing wound		6 months or less