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

Diabetic Foot Clinical Trial

Official title:

ESWT Treatment of Diabetic Foot VS. Standard Care Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01499472
• Other study ID #: ofer02-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 4, 2011
• Last updated: December 22, 2011
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: August 2011
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel:Ministry of Health - Director General
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Device:
• shock wave therapy
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
• dermagold shockwave
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.

Procedure:
• standard of care
regular care including debridement and bandaging.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healed ulcer		6 months	No