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

Diabetic Foot Ulcers Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02691234
• Other study ID #: 0592-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 31, 2016
• Last updated: February 21, 2016
• Start date: April 2016

Study information

• Verified date: January 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer

Intervention

Device:
• Extracorporeal Shockwave Therapy and debridement

Other:
• debridement and cleaning

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No