Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds

NCT03061461 | Unknown FDA Device

• 1 other identifier: NMRR-16-1660-32178 (IIR)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) as performed by Zoech (JATROS Orthop 2009;(1):46-47) is effective and safe in treatment of chronic soft tissue wounds, and is statistically significantly more effective than sham-treatment of chronic soft tissue wounds.

Conditions

Wound of Skin

Keywords

Extracorporeal shock wave therapy; ESWT; Radial extracorporeal shock wave therapy; rESWT; Diabetes

Outcome Measures

Primary Outcomes (1)

• Wound size

  Individual time necessary to convert a chronic soft tissue wound from Grade/Stage 1A, 1C, 2A or 2C according to Armstrong et al. (Diabetes Care 1998;21:855-859) into Grade/Stage 0A or 0C according to Armstrong et al. (1998) (i.e., lesion completely epithelialized).

  Three months after start of the treatments

Secondary Outcomes (3)

• Comfort during treatment

  Immediately after each treatment session

• Pain intensity during treatment

  Immediately after each treatment session

• Satisfaction

  Three months after start of the treatments

Study Arms (2)

rESWT

ACTIVE COMPARATOR

Treatment of chronic wounds with the Swiss DolorClast (Electro Medical Systems S.A., Nyon, Switzerland) and the EvoBlue handpiece as follows: * Use of the 15-mm applicator or the 36-mm applicator of the Swiss DolorClast according to the individual wound size. * Six treatment sessions, two treatment sessions per week. * 1000 radial shock waves per cm\^2 wound and treatment session. * Energy flux density 0.07 mJ/mm\^2 (i.e., setting of the air pressure of the Swiss DolorClast at 2 bar when using the 15-mm applicator, and at 4 bar when using the 36-mm applicator). * Frequency of the radial shock waves set at 15 Hz.

Device: rESWT

Sham rESWT

SHAM COMPARATOR

Treatment of chronic wounds with the Swiss DolorClast (Electro Medical Systems S.A., Nyon, Switzerland) and the placebo EvoBlue handpiece of the Swiss DolorClast (that looks and sounds like the EvoBlue handpiece of the Swiss DolorClast, but does not generate radial shock waves) as follows: * Use of the 15-mm applicator or the 36-mm applicator of the Swiss DolorClast according to the individual wound size. * Six treatment sessions, two treatment sessions per week. * 1000 sham radial shock waves per cm\^2 wound and treatment session. * Energy flux density 0.00 mJ/mm\^2 (setting of the air pressure of the Swiss DolorClast at 2 bar when using the 15-mm applicator, and at 4 bar when using the 36-mm applicator). * Frequency of the sham radial shock waves set at 15 Hz.

Device: Sham rESWT

Interventions

rESWT DEVICE

All patients will receive standard care as follows: 1. Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee. 2. The clean wounds will be assessed using the TIME concept. 3. Treatment with rESWT. 4. Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin, Smith \& Nephew, Inc. Advanced Wound Management; Fort Worth, TX, USA). In addition, patients in arm "rESWT" will receive rESWT between Steps 2 and 3 of standard care as outlined in arm description "rESWT".

rESWT

Sham rESWT DEVICE

All patients will receive standard care as follows: 1. Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee. 2. The clean wounds will be assessed using the TIME concept. 3. Treatment with sham rESWT. 4. Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin). In addition, patients in arm "Sham rESWT" will receive sham rESWT between Steps 2 and 3 of standard care as outlined in arm description "Sham rESWT".

Sham rESWT

Eligibility Criteria

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

You may qualify if:

• adults (both male and female) with chronic soft tissue wounds
• age range: between 18 and 80 years
• willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient
• different kinds of chronic soft tissue wounds: diabetic foot ulcers, post traumatic, venous stasis ulcer, decubitus
• wounds scored as Grade/Stage 1A, 1C, 2A and 2C according to Armstrong et al. (Diabetes Care 1998;21:855-859)
• No contraindications for rESWT

You may not qualify if:

• children and teenagers below the age of 18
• no willingness of the patient to participate in the study, and/or written informed consent not signed and not personally dated by the patient
• wounds scored as Grade/Stage 0A, 0B, 0C, 0D, 1B, 1D, 2B, 2D, 3A, 3B, 3C or 3D according to Armstrong et al. (1998)
• Burn wounds
• Uncontrolled diabetes because glycaemic control is crucial for wound healing and erratic values will effect the study results
• Blood sugar levels of the patient before meals are NOT regularly higher than 7mmol/L and are NOT regularly higher than 11mmol/L one to two hours after meals)
• Contraindications of rESWT: treatment of (i) soft tissue wounds over air-filled tissue (lung, gut), (ii) pregnant patients, (iii) patients with blood-clotting disorders (including local thrombosis), (iv) patients treated with oral anticoagulations, (v) soft tissue wounds above local tumors, and (vi) patients treated with local corticosteroid applications in the time period of six weeks before the first rESWT session (if applicable).

Sponsors & Collaborators

• Kuala Lumpur General Hospital: lead

Study Sites (1)

Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur Hospital

Kuala Lumpur, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Harikrishna KR Nair, MD

  Hospital Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harikrishna KR Nair, MD

CONTACT

+6-12-2920235; hulk25@hotmail.com

Karina Koh, MD

CONTACT

+6-03-2615 5555; karinakoh@crc.moh.gov.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A medical assistant in the Wound Care Unit, Dept on Internal Medicine, Kuala Lumpur Hospital (Kuala Lumpur, Malaysia) will allocate interventions by means of opaque sealed envelopes that will be marked according to the allocation schedule. The medical assistant will be unaware of the size of the blocks. The randomized intervention assignment as outlined above will be concealed from both patients and health care staff until recruitment will be complete and irrevocable. Therapists applying the treatments will not be blinded. All assessments before the first treatment (baseline) and during the follow-up period (either three months after start of the treatments or until complete epithelialization, respectively) will be performed by assessors blind to the intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Wound Care Unit, Dept. of Internal Medicine, KualaLGH

Model Details: Randomized controlled trial (RCT), no blinding of therapists applying the treatments, blinding of patients, blinding of evaluators. Partial cross-over design: patients in the control group will be offered to be treated with rESWT starting three months after the last sham treatment. This will guarantee that every patient will receive a real rESWT treatment independent of blind allocation to one of the treatment groups.

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 23, 2017
• Study Start: February 23, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)