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Diabetic foot complications are a common and costly problem. Excessive plantar pressures due to foot deformities and/or limited ankle dorsiflexion, especially in the presence of peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers. Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot ulcers.
Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology) was effective in treating subjects with chronic heel pain and Achilles tendonitis with no serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to perform more effective stretching exercises and may prevent recurrence of diabetic foot ulcers.
The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk subjects with a history of diabetic foot ulcer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shockwave with manual manipulation | Experimental | A shockwave (EPAT) therapy with two supervised manual manipulation per week |
|
| Manual manipulation | Active Comparator | A Placebo (no) shockwave with two supervised manual manipulations per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-corporeal pulsed-activated therapy or shockwave therapy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks | at baseline visit and at 4 weeks | |
| Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks. | at baseline visit and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months. | at 1 month and at 3 months | |
| Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months. | at 1 month and at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsup Song, D.P.M., Ph.D. | Contact | 215-625-5369 | jsong@temple.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jinsup Song, DPM, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gait Study Center at the Temple University School of Podiatric Medicine | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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