Developing a Diabetic Foot Ulcer Protocol

Withdrawn before enrolling · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT01068171

Run by

The University of Texas Health Science Center, Houston

People needed

0

Starts

2010-05-01

Expected to finish

2012-06-01

Last updated by the study team

2020-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Harris County Hospital District Community Health — Houston, Texas, United States

Full record on ClinicalTrials.gov

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