Developing a Diabetic Foot Ulcer Protocol

Status Withdrawn

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01068171
Study type	Interventional
Source	The University of Texas Health Science Center, Houston
Contact
Status	Withdrawn
Phase	N/A
Start date	May 2010
Completion date	June 2012

View Details

See also
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