Study to Determine if Shock Wave Therapy Applied to Traumatic Wounds of the Extremity Improves Healing Time
NCT ID: NCT00486733
Last Updated: 2012-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
213 participants
INTERVENTIONAL
2007-04-30
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard of Care
Standard of Care Treatment; no study treatment
No interventions assigned to this group
Standard of Care plus Study Treatment
Standard of Care Treatment plus study treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Tissue Regeneration Technologies
INDUSTRY
Walter Reed Army Medical Center
FED
Responsible Party
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Alexander Stojadinovic
Director, Combat Wound Initiative Program
Principal Investigators
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Alexander Stojadinovic, MD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed Army Medical Center
Locations
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Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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References
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Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.
Wang CJ, Chen HS, Chen CE, Yang KD. Treatment of nonunions of long bone fractures with shock waves. Clin Orthop Relat Res. 2001 Jun;(387):95-101. doi: 10.1097/00003086-200106000-00013.
Schaden W, Fischer A, Sailler A. Extracorporeal shock wave therapy of nonunion or delayed osseous union. Clin Orthop Relat Res. 2001 Jun;(387):90-4. doi: 10.1097/00003086-200106000-00012.
Ludwig J, Lauber S, Lauber HJ, Dreisilker U, Raedel R, Hotzinger H. High-energy shock wave treatment of femoral head necrosis in adults. Clin Orthop Relat Res. 2001 Jun;(387):119-26. doi: 10.1097/00003086-200106000-00016.
Meirer R, Kamelger FS, Huemer GM, Wanner S, Piza-Katzer H. Extracorporal shock wave may enhance skin flap survival in an animal model. Br J Plast Surg. 2005 Jan;58(1):53-7. doi: 10.1016/j.bjps.2004.04.027.
Haupt G, Chvapil M. Effect of shock waves on the healing of partial-thickness wounds in piglets. J Surg Res. 1990 Jul;49(1):45-8. doi: 10.1016/0022-4804(90)90109-f.
Ludwig J, Lauber S, Lauber J, Hotzinger H. [Shockwave treatment of femur head necrosis in the adult]. Z Orthop Ihre Grenzgeb. 1999 Jul-Aug;137(4):Oa2-5. No abstract available. German.
Lauber S. [High energy extracorporeal shockwave therapy in femur head necrosis]. Z Orthop Ihre Grenzgeb. 2000 Sep-Oct;138(5):Oa3-4. No abstract available. German.
Gerdesmeyer L, von Eiff C, Horn C, Henne M, Roessner M, Diehl P, Gollwitzer H. Antibacterial effects of extracorporeal shock waves. Ultrasound Med Biol. 2005 Jan;31(1):115-9. doi: 10.1016/j.ultrasmedbio.2004.08.022.
Other Identifiers
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06-20028
Identifier Type: -
Identifier Source: org_study_id