NCT01068171

Developing a Diabetic Foot Ulcer Protocol

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-02-12
• Last updated: 2020-11-05

Locations

1 site across 1 country: United States