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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Walter Reed Army Medical Center
Sponsor:
Collaborator:
Tissue Regeneration Technologies
Information provided by (Responsible Party):
Alexander Stojadinovic, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT00486733
First received: June 13, 2007
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Soft Tissue Injuries
Device: DermaGold
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The number of shock wave treatments performed. [ Time Frame: Within six weeks following initial treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Durability of wound closure (i.e., status of wound at one month following determination of "healed"). [ Time Frame: 90 days following initial treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Length of hospital stay and number of surgical procedures for the extremity wound selected for study [ Time Frame: 90 days following initial treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 213
Study Start Date: April 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486733

Contacts
Contact: Tiffany Felix, MS 251-300-7397 tfelix@hjfresearch.org

Locations
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
Investigators
Principal Investigator: Alexander Stojadinovic, MD Walter Reed Army Medical Center
  More Information

Publications:
Responsible Party: Alexander Stojadinovic, Director, Combat Wound Initiative Program, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT00486733     History of Changes
Other Study ID Numbers: 06-20028
Study First Received: June 13, 2007
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Medical Center:
extracorporeal shock wave therapy
soft tissue wounds

Additional relevant MeSH terms:
Soft Tissue Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014