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

Hadassah Medical Center

Status: Unknown

Conditions: Diabetic Foot

Treatments: Procedure: standard of care; Device: shock wave therapy; Device: dermagold shockwave

Study type: Interventional

Funder types: Other

Identifiers

NCT01499472

ofer02-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

shock wave therapy, shortened wound healing time

Active Comparator group

Treatment:

Device: shock wave therapy

Device: dermagold shockwave

normal wound care

Other group

Description:

standard of care intervention

Treatment:

Procedure: standard of care