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

Phase 1

• Conditions: Diabetic Foot Ulcers
• Interventions: Device: Extracorporeal Shockwave Therapy and debridement; Other: debridement and cleaning

• 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

Arm && Interventions

Group	Intervention	Description
Extracorporeal Shockwave Therapy and debridement	debridement and cleaning	The treatment will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing before each treatment. The transducer device will be positioned against the lesion area and shockwaves will be delivered at a gradually increasing energy, with a maximum energy level of 0.09mJ/mm2
debridement and cleansing.	debridement and cleaning	The standard treatment to the control group and the treatment group will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing. The physician will treat the patient in regard to his medical state: antibiotic medication if needed, dressing and off loading with Orthotic devices
Extracorporeal Shockwave Therapy and debridement	Extracorporeal Shockwave Therapy and debridement	The treatment will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing before each treatment. The transducer device will be positioned against the lesion area and shockwaves will be delivered at a gradually increasing energy, with a maximum energy level of 0.09mJ/mm2

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