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

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diabetic Foot Ulcers

Treatments: Other: debridement and cleaning; Device: Extracorporeal Shockwave Therapy and debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT02691234

0592-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Extracorporeal Shockwave Therapy and debridement

Experimental group

Description:

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

Treatment:

Other: debridement and cleaning

Device: Extracorporeal Shockwave Therapy and debridement

debridement and cleansing.

Active Comparator group

Description:

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

Treatment:

Other: debridement and cleaning