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

Study Overview
=================
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.

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Device: Extracorporeal Shockwave Therapy and debridement
* Other: debridement and cleaning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic non-healing diabetic foot ulcers for more than 2 months. Age 18-80 years Ankle Brachial Index (ABI) ≥0.6 Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm The target ulcer is up to Wagner's grade 3 Albumin level ≥25g/L Hemoglobin level ≥90g/L Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2 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: Pregnancy or lactation ABI <0.6 The long diameter of the target ulcer is >7cm and the short diameter is <1cm The target ulcer is of Wagner's grade 4 or above Severe Hypoalbuminemia <25g/L Severe anemia, Hemoglobin level <90g/L eGFR <30ml/min/1.73m2 Patients suffering from acute Charcot foot Severe edema of the treated limb Patient with present malignancy or past malignancy in the treated area Systemic chemotherapy/ radiation treatment within the last 6 months Deep vein thrombosis within the last 6 months Any other experimental treatment or participation in other studies -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extracorporeal Shockwave Therapy and debridement<br>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 | Device: Extracorporeal Shockwave Therapy and debridement<br> <br> Other: debridement and cleaning<br> <br> |
| Active Comparator: debridement and cleansing.<br>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 | Other: debridement and cleaning<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |