Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers

Not Applicable

• Conditions: Diabetic Foot
• Interventions: Device: shock wave therapy; Procedure: standard of care; Device: dermagold shockwave

• Registration Number: NCT01499472
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-09-04
• Study First Submitted QC: 2011-12-22
• Last Update Submitted: 2011-12-22
• Study First Posted: 2011-12-26
• Last Update Posted: 2011-12-26
• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Signed Informed Consent.
2. Diagnosed with Diabetes.
3. An Active Diabetic Ulcer larger than 5 cm2
4. Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)>=0.5

Exclusion Criteria

1. Pregnancy.

2. The patient is under another research protocol.

3. One of the following:

   A. ABI<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.

4. The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.

5. Sufficient Noncompliant.

6. Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shock wave therapy, shortened wound healing time	shock wave therapy	-
shock wave therapy, shortened wound healing time	dermagold shockwave	-
normal wound care	standard of care	standard of care intervention

Primary Outcome Measures

Name	Time	Method
healed ulcer	6 months