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

NCT00486733 | Unknown Phase 3 DMC

• 1 other identifier: 06-20028
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Injuries

Keywords

extracorporeal shock wave therapy; soft tissue wounds

Outcome Measures

Primary Outcomes (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.

  90 days following initial treatment

Secondary Outcomes (11)

• Total number of study subjects with a final status of "healed" in the ESWT therapy group versus control group.

  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.

  90 days following intitial treatment

• The number of shock wave treatments performed.

  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.

  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").

  28 days following inititial treatment

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care Treatment; no study treatment

Standard of Care plus Study Treatment

EXPERIMENTAL

Standard of Care Treatment plus study treatment

Device: DermaGold

Interventions

DermaGold DEVICE

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.

Standard of Care plus Study Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead
• Tissue Regeneration Technologies: collaborator

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

RECRUITING

Related Publications (9)

• Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.

  PMID: 12846521 BACKGROUND

• 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.

  PMID: 11400901 BACKGROUND

• 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.

  PMID: 11400900 BACKGROUND

• 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.

  PMID: 11400872 BACKGROUND

• 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.

  PMID: 15629167 BACKGROUND

• 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.

  PMID: 2359293 BACKGROUND

• 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.

  PMID: 11051007 BACKGROUND

• 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.

  PMID: 11084728 BACKGROUND

• 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.

  PMID: 15653238 BACKGROUND

MeSH Terms

Conditions

Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Alexander Stojadinovic, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Felix, MS

CONTACT

251-300-7397; tfelix@hjfresearch.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Combat Wound Initiative Program

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 15, 2007
• Study Start: April 1, 2007
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

US (1)