Study to Determine if Shock Wave Therapy Applied to Traumatic Wounds of the Extremity Improves Healing Time (CWI)

December 18, 2012 updated by: Alexander Stojadinovic, Walter Reed Army Medical Center

Prospective Randomized Trial of Standard Wound Care Versus Standard Wound Care Plus Shock Wave Therapy for Traumatic Wounds of the Extremity

The purpose of this study is to determine if adding shock wave therapy to standard-of-care wound treatment for traumatic extremity wounds helps them heal faster.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Timely return of combat wounded to functional lives and duty is imperative. Reliance upon traditional wound management principles is restrictive, and a treatment paradigm aimed at high-energy projectile contaminated wounds suits the requirements of our combat casualty care program. The nature of war wounds makes them unsuitable for conventional, saline-soaked-gauze dressings.

Extra-corporeal-shockwave-therapy (ESWT) has been used successfully for orthopedic soft tissue indications. Pilot studies indicate that ESWT enhances tissue healing through growth-factor release and neovascularization, with favorable safety profile and anti-bacterial effect, particularly in problematic wounds including fracture non-unions, post-traumatic wounds, and burns.

The need to improve the healing and quality-of-life of the combat wounded, the potential of this minimal-risk technology to improve healing of difficult-to-treat orthopedic/soft tissue injury and infection, as well as the combat casualty care experience of surgeons at WRAMC, dovetail uniquely to have our wounded soldiers and medical center play a pivotal role as the fundamental proving ground and primary beneficiary of this technology.

Comparison(s): Standard-of-care wound therapy compared to standard-of-care wound therapy + ESWT for extremity wounds with the aim of conducting a definitive critical analysis of the role of ESWT in improved treatment and outcomes of traumatic soft tissue injuries of the extremity.

Study Type

Interventional

Enrollment (Anticipated)

213

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Recruiting
        • Walter Reed Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should be 18 years of age or older, and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy.
  • Written informed consent must be obtained from each patient prior to entering the study.
  • Female patients will not be pregnant. Exclusion of the possibility of pregnancy by HCG testing (urine or serum) or by history (tubal ligation, hysterectomy, or menopause) is required prior to inclusion in the study.
  • Patients should be willing to be followed within the military healthcare system, or the participating civilian center during the course of study treatment and follow-up.
  • Patients with traumatic wound(s) of the upper and/or lower extremity. The study wound is the wound with the highest Red Cross Wound Classification (RCWC).
  • Patients should demonstrate adequacy of limb perfusion by all of the following clinical parameters in the affected extremity to be treated by investigational shock wave therapy: Palpable distal extremity pulse; Absence of compartment syndrome; or Ankle Brachial Index(ABI) ≥ 0.9 or transcutaneous pulse oximetry, tcP02≥20mmHg.
  • Patients with non-circumferential, second degree burn wounds of the upper and/or lower extremity.

Exclusion Criteria:

  • Patients with current participation in another clinical investigation of a medical device or a drug the requirements of which may preclude complete involvement in this study.
  • Women who are pregnant.
  • One or more of the following findings in the affected extremity to be treated by investigational shock wave therapy: Ankle Brachial Index < 0.9 or tcP02<20 mmHg; Significant arterial or venous injury requiring surgical intervention; or Lymphedema.
  • Subject has another non-superficial wound near the study wound that is less than 3cm from the study wound or that has a RCWC of 3.
  • Active or previous (within 60 days prior to the study screening visit) chemotherapy.
  • Active or previous (within 60 days prior to the study screening visit) radiation to the affected extremity to be treated by investigational shock wave therapy.
  • Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits.
  • The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements.
  • Patients with 1st degree, 3rd degree, or circumferential extremity burns considered for treatment by investigational shock wave therapy.
  • History of sickle cell anemia.
  • History of infection with Human Immunodeficiency Virus.
  • History of immunodeficiency disorders.
  • Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females).
  • Deep vein thrombosis within 6 months of study screening visit.
  • Chronic renal insufficiency requiring dialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Standard of Care Treatment; no study treatment
Experimental: Standard of Care plus Study Treatment
Standard of Care Treatment plus study treatment
The first four follow-up study assessment and data collection points will coincide with scheduled operative interventions on the wound guided by clinical situation and the treating physician's judgment (approximately every 3-4 days). Subsequent follow-up study assessment and data collection points will occur on study days 28 ± 3, 42 ± 3, 60 ± 3, and 90 ± 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to complete wound healing. For purposes of this study, the definition of "healed" is wound closure with total epithelialization of the soft tissue defect, confirmed at two consecutive study visits.
Time Frame: 90 days following initial treatment
90 days following initial treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Total number of study subjects with a final status of "healed" in the ESWT therapy group versus control group.
Time Frame: 90 days following initial treatment
90 days following initial treatment
The percentage of the soft tissue wound that has healed at 90 days as assessed by planimetric computerized digital measurement.
Time Frame: 90 days following intitial treatment
90 days following intitial treatment
The number of shock wave treatments performed.
Time Frame: Within six weeks following initial treatment
Within six weeks following initial treatment
For patients who have not achieved healed status at Day 90, the percent of wounds at Day 90 with lesser healing (≤50% epithelialization) versus with greater healing (>50% but < 100% epithelialization) as determined by planimetric CDM.
Time Frame: 90 days following initial treatment
90 days following initial treatment
Results of quantitative wound bacterial cultures (wounds with a quantitative wound bacterial count greater than 105 per gram of tissue will be defined as an "infected wound").
Time Frame: 28 days following inititial treatment
28 days following inititial treatment
Durability of wound closure (i.e., status of wound at one month following determination of "healed").
Time Frame: 90 days following initial treatment
90 days following initial treatment
Serial wound punch biopsies for quantitative bacterial cultures, bacterial 16sRNA, and molecular analysis of 185 relevant wound healing genes.
Time Frame: 28 days following intitial treatment
28 days following intitial treatment
Serum from venous blood and Vacuum Assisted Wound Closure Device (VAWCD) effluent for biomarkers, C-reactive protein, and cortisol levels.
Time Frame: 28 days following initial treatment
28 days following initial treatment
Mean wound surface area, circumference, depth and estimated volumes over time, ESWT group versus control group, as determined by CDM planimetry surface measurements.
Time Frame: 90 days following initial treatment
90 days following initial treatment
Length of hospital stay and number of surgical procedures for the extremity wound selected for study
Time Frame: 90 days following initial treatment
90 days following initial treatment
Assessment of relative burden of disease (trauma) between treatment groups by comparing mean values of the eight standard scales of the Medical Outcome Study 36-Item Short Form Health Survey (SF-36).
Time Frame: 90 days following intitial treatment
90 days following intitial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexander Stojadinovic, MD, Walter Reed Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

June 13, 2007

First Submitted That Met QC Criteria

June 13, 2007

First Posted (Estimate)

June 15, 2007

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 18, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-20028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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