Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44DK059074 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar MTH foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 02 | Active Comparator | Current standard of care insole |
|
| 01 | Experimental | TrueContour® insole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueContour® Insole | Device | Novel designed insole |
| |
| Current standard of care insole |
| Measure | Description | Time Frame |
|---|---|---|
| The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer | every 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph L Loomis, MS | DIApedia, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl T Hayden VA Medical Center | Phoenix | Arizona | 85012 | United States | ||
| Southern Arizona Limb Salvage Alliance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24760263 | Derived | Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR. Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes Care. 2014 Jul;37(7):1982-9. doi: 10.2337/dc13-2956. Epub 2014 Apr 23. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| D003920 | Diabetes Mellitus |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
Current Medicare approved A5513 insole |
|
| Tucson |
| Arizona |
| 85711 |
| United States |
| Center for Clinical Research, Inc | Castro Valley | California | 94546 | United States |
| Innovative Medical Technologies | Los Angeles | California | 90024 | United States |
| Diabetic Foot and Wound Center | Denver | Colorado | 80220 | United States |
| Weil Foot & Ankle Institute | Des Plaines | Illinois | 60016 | United States |
| Hines VA Hospital | Hines | Illinois | 60141 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44193 | United States |
| Blair Medical Associates, Inc | Altoona | Pennsylvania | 16602 | United States |
| Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | United States |
| Complete Family Footcare | McAllen | Texas | 78501 | United States |
| D012883 |
| Skin Ulcer |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |