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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00486733
Recruitment Status : Unknown
Verified December 2012 by Alexander Stojadinovic, Walter Reed National Military Medical Center.
Recruitment status was:  Recruiting
First Posted : June 15, 2007
Last Update Posted : December 20, 2012
Tissue Regeneration Technologies
Information provided by (Responsible Party):
Alexander Stojadinovic, Walter Reed National Military Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Injuries Device: DermaGold Phase 3

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  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Standard Wound Care Versus Standard Wound Care Plus Shock Wave Therapy for Traumatic Wounds of the Extremity
Study Start Date : April 2007
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Device: DermaGold
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. The number of shock wave treatments performed. [ Time Frame: Within six weeks following initial treatment ]
  4. 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 ]
  5. 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 ]
  6. Durability of wound closure (i.e., status of wound at one month following determination of "healed"). [ Time Frame: 90 days following initial treatment ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Length of hospital stay and number of surgical procedures for the extremity wound selected for study [ Time Frame: 90 days following initial treatment ]
  11. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00486733

Contact: Tiffany Felix, MS 251-300-7397

United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Tissue Regeneration Technologies
Principal Investigator: Alexander Stojadinovic, MD Walter Reed Army Medical Center

Responsible Party: Alexander Stojadinovic, Director, Combat Wound Initiative Program, Walter Reed National Military Medical Center Identifier: NCT00486733     History of Changes
Other Study ID Numbers: 06-20028
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by Alexander Stojadinovic, Walter Reed National Military Medical Center:
extracorporeal shock wave therapy
soft tissue wounds

Additional relevant MeSH terms:
Soft Tissue Injuries
Wounds and Injuries