Trial record 9 of 39 for:
shoes | Open Studies
Developing a Diabetic Foot Ulcer Protocol
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by The University of Texas Health Science Center, Houston.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The University of Texas Health Science Center, Houston
Collaborators:
Harris County Hospital District
Baylor College of Medicine
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01068171
First received: February 11, 2010
Last updated: December 3, 2010
Last verified: December 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetic Foot Ulcers |
Other: type of footwear Other: collagen dressing with and without silver |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Developing a Diabetic Foot Ulcer Protocol in a Multi-ethnic, Underserved Population |
Resource links provided by NLM:
Further study details as provided by The University of Texas Health Science Center, Houston:
Primary Outcome Measures:
- decrease in size of wound [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- non-healing wound [ Time Frame: 6 months or less ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: shoe, plain dressing
post-op shoe with plain occlusive dressing
|
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 Names:
|
|
Active Comparator: shoe, collagen
post-op shoe with collagen dressing
|
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
Other Names:
|
|
Active Comparator: boot, plain dressing
air boot with occlusive dressing
|
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 Names:
|
|
Active Comparator: boot, collagen
air boot with collagen dressing
|
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
Other Names:
|
|
Active Comparator: monitored air boot, plain dressing
air boot with retention strap to monitor whether boot is removed with occlusive dressing
|
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 Names:
|
|
Active Comparator: monitored boot with collagen
air boot with retention strap to monitor whether boot is removed with collagen dressing
|
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
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068171
Contacts
| Contact: Talar L Glover, MS, RN, CNS | 713-566-2513 | talar_glover@hchd.tmc.edu |
| Contact: Gary Lepow, DPM | 713-790-0530 | docgml@aol.com |
Locations
| United States, Texas | |
| Harris County Hospital District Community Health | Recruiting |
| Houston, Texas, United States, 77054 | |
| Contact: Talar L Glover, MS, RN, CNS 713-566-2513 talar_glover@hchd.tmc.edu | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Harris County Hospital District
Baylor College of Medicine
Investigators
| Principal Investigator: | Gary Lepow, DPM | University of Texas Health Science at Houston, Baylor College of Medicine |
| Principal Investigator: | Talar L Glover, MS, RN, CNS | Harris County Hospital District |
More Information
No publications provided
| Responsible Party: | Gary Lepow - Chief of Podiatry, UT Health Science Center - Houston and Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT01068171 History of Changes |
| Other Study ID Numbers: | HSC-GEN-09-0418 |
| Study First Received: | February 11, 2010 |
| Last Updated: | December 3, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center, Houston:
|
diabetes foot ulcers off-loading collagen Wagner 1 |
Additional relevant MeSH terms:
|
Ulcer Foot Ulcer Diabetic Foot Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 16, 2013