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The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| shock wave therapy, shortened wound healing time | Active Comparator |
| |
| normal wound care | Other | standard of care intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shock wave therapy | Device | shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| healed ulcer | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy.
The patient is under another research protocol.
One of the following:
A. ABI<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.
The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
Sufficient Noncompliant.
Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids
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| dermagold shockwave | Device | shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments. |
|
| standard of care | Procedure | regular care including debridement and bandaging. |
|
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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