Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-05-31
2012-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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shoe, plain dressing
post-op shoe with plain occlusive dressing
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
shoe, collagen
post-op shoe with collagen dressing
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
boot, plain dressing
air boot with occlusive dressing
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
boot, collagen
air boot with collagen dressing
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
monitored air boot, plain dressing
air boot with retention strap to monitor whether boot is removed with occlusive dressing
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
monitored boot with collagen
air boot with retention strap to monitor whether boot is removed with collagen dressing
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Harris County Hospital District
OTHER_GOV
Baylor College of Medicine
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Principal Investigators
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Gary Lepow, DPM
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science at Houston, Baylor College of Medicine
Talar L Glover, MS, RN, CNS
Role: PRINCIPAL_INVESTIGATOR
Harris County Hospital District
Locations
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Harris County Hospital District Community Health
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-GEN-09-0418
Identifier Type: -
Identifier Source: org_study_id