Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers

Phase 1

• Conditions: Diabetic Foot Ulcers

• Registration Number: NCT02691234
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis.

The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave treatment will be done together with the standard conventional treatment for DFUs, compared to a control group who will receive the same conventional standard of care.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-31
• Study First Submitted QC: 2016-02-21
• Last Update Submitted: 2016-02-21
• Study First Posted: 2016-02-25
• Last Update Posted: 2016-02-25
• Study Start: 2016-04
• Primary Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Chronic non-healing diabetic foot ulcers for more than 2 months.
2. Age 18-80 years
3. Ankle Brachial Index (ABI) ≥0.6
4. Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm
5. The target ulcer is up to Wagner's grade 3
6. Albumin level ≥25g/L
7. Hemoglobin level ≥90g/L
8. Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2
9. The patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements

Exclusion Criteria

1. Pregnancy or lactation

2. ABI <0.6

3. The long diameter of the target ulcer is >7cm and the short diameter is <1cm

4. The target ulcer is of Wagner's grade 4 or above

5. Severe Hypoalbuminemia <25g/L

6. Severe anemia, Hemoglobin level <90g/L

7. eGFR <30ml/min/1.73m2

8. Patients suffering from acute Charcot foot

9. Severe edema of the treated limb

10. Patient with present malignancy or past malignancy in the treated area

11. Systemic chemotherapy/ radiation treatment within the last 6 months

12. Deep vein thrombosis within the last 6 months

13. Any other experimental treatment or participation in other studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess initial closure rate of the wound 4 weeks after the last treatment session, as compared to the control group receiving conventional standard of care.	four weeks