Diabetic Foot
Conditions
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.
Interventions
DEVICEshock wave therapy
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
DEVICEdermagold shockwave
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
PROCEDUREstandard of care
regular care including debridement and bandaging.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| healed ulcer | 6 months |
Outcome results
None listed