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

NCT02691234 | Unknown Phase 1

• 1 other identifier: 0592-HMO-CTIL
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Extracorporeal Shockwave Therapy and debridement

EXPERIMENTAL

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; Other: debridement and cleaning

debridement and cleansing.

ACTIVE COMPARATOR

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

Interventions

Extracorporeal Shockwave Therapy and debridement DEVICE

Extracorporeal Shockwave Therapy and debridement

debridement and cleaning OTHER

Extracorporeal Shockwave Therapy and debridement; debridement and cleansing.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Conditions

Diabetic Foot

Interventions

Extracorporeal Shockwave Therapy; Debridement

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 25, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Last Updated: February 25, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share