Study to Determine if Shock Wave Therapy Applied to Traumatic Wounds of the Extremity Improves Healing Time (CWI)
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 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|
- 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 ]
- 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 ]
|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)|
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.
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.
|Contact: Tiffany Felix, MSfirstname.lastname@example.org|
|United States, District of Columbia|
|Walter Reed Army Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20307|
|Principal Investigator:||Alexander Stojadinovic, MD||Walter Reed Army Medical Center|