Diabetic Foot Ulcers Clinical Trial
— ITCCOfficial title:
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
Verified date | August 2020 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 225 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Parkland Health & Hospital Systems | Dallas | Texas |
United States | UT Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Scott & White | Temple | Texas |
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Achieve Full Wound Healing. | We will evaluate wounds at each clinical visit. An ulcer will be considered "healed" when it is fully epithelialized with no drainage. | 20 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02652754 -
Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers
|
Phase 1 | |
Completed |
NCT01070433 -
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
Completed |
NCT00971048 -
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
|
N/A | |
Terminated |
NCT00762138 -
The AutoloGel™ Post-Market Surveillance (TAPS) Program
|
N/A | |
Completed |
NCT00578604 -
Non-Invasive Assessment of Wound Healing With Optical Methods
|
N/A | |
Completed |
NCT05417425 -
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
|
Phase 1 | |
Completed |
NCT02631512 -
Evaluation of Woulgan in Diabetic Foot Ulcer
|
Phase 4 | |
Terminated |
NCT01816633 -
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
|
N/A | |
Completed |
NCT02222376 -
Effect of Topic Pirfenidone in Diabetic Ulcers
|
Phase 3 | |
Completed |
NCT01454401 -
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
|
N/A | |
Withdrawn |
NCT01105884 -
Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers
|
N/A | |
Completed |
NCT01291160 -
Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
|
Phase 2/Phase 3 | |
Completed |
NCT00536744 -
Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers
|
Phase 3 | |
Terminated |
NCT00316537 -
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
|
Phase 1/Phase 2 | |
Completed |
NCT00013299 -
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
|
Phase 2 | |
Completed |
NCT00013286 -
A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk
|
Phase 2 | |
Terminated |
NCT02667327 -
A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer
|
Phase 3 | |
Not yet recruiting |
NCT00916292 -
Safety Study of Topical Human FGF-1 for Wound Healing
|
Phase 1 | |
Completed |
NCT01154374 -
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
|
Phase 2 | |
Not yet recruiting |
NCT02672280 -
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
|
Phase 1/Phase 2 |