N/A
N=225
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
Diabetic Foot Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT01221207 ↗Enrolled (actual)
225
Serious AEs
14.2%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants Who Achieve Full Wound Healing. — 35; 63; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Total Contact Cast (Device); Instant Total Contact Cast (ITCC) (Device); Removable Cast Walker (RCW) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieve Full Wound Healing. |
35; 63; 37 | — |
Summary
Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week randomized clinical trial of 225 patients in community care in three university medical center diabetes clinics.
Aim 2. To compare the frequency of complications such as soft tissue and bone infections, iatrogenic wounds, falls and fall related injuries, and amputations among patients treated with TCC, ITCC and RCW to heal diabetic foot ulcers.
Aim 3. To compare patient compliance and level of activity among TCC, ITCC, RCW treatment groups. Using computerized activity monitors which time-stamp each step, we will evaluate both degree and magnitude of activity between groups.
Aim 4. To evaluate the cost of diabetic foot ulcer-related treatment and complications during the course of therapy.
Eligibility Criteria
Inclusion Criteria
- Men or women 18 years old or older
- One or more foot ulcers without clinical evidence of osteomyelitis
- Diagnosis of Diabetes Mellitus
- University of Texas Grade 1A-B, 2A-B or 3A-B
- ABI >0.5
- Spanish-speaking subjects will be eligible to participate
Exclusion Criteria
- Active Charcot Arthropathy
- ABI <0.5
- Gangrene, active infection
- Unable to keep research appointments
- Wide spread malignancy or systemically immunocompromising disease
- Alcohol or substance abuse within 6 months
- Unreliable, unwilling or unable to comprehend informed consent
Data sourced from ClinicalTrials.gov (NCT01221207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.