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

Primary Purpose

Soft Tissue Injuries

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

DermaGold

About this trial

This is an interventional treatment trial for Soft Tissue Injuries focused on measuring extracorporeal shock wave therapy, soft tissue wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Walter Reed Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Standard of Care plus Study Treatment

Arm Description

Standard of Care Treatment; no study treatment

Standard of Care Treatment plus study treatment

Outcomes

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.

Secondary Outcome Measures

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

The percentage of the soft tissue wound that has healed at 90 days as assessed by planimetric computerized digital measurement.

The number of shock wave treatments performed.

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.

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").

Durability of wound closure (i.e., status of wound at one month following determination of "healed").

Serial wound punch biopsies for quantitative bacterial cultures, bacterial 16sRNA, and molecular analysis of 185 relevant wound healing genes.

Serum from venous blood and Vacuum Assisted Wound Closure Device (VAWCD) effluent for biomarkers, C-reactive protein, and cortisol levels.

Mean wound surface area, circumference, depth and estimated volumes over time, ESWT group versus control group, as determined by CDM planimetry surface measurements.

Length of hospital stay and number of surgical procedures for the extremity wound selected for study

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).

Full Information

NCT ID

NCT00486733

First Posted

June 13, 2007

Last Updated

December 18, 2012

Sponsor

Walter Reed Army Medical Center

Collaborators

Tissue Regeneration Technologies

1. Study Identification

Unique Protocol Identification Number

NCT00486733

Brief Title

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

Acronym

CWI

Official Title

Prospective Randomized Trial of Standard Wound Care Versus Standard Wound Care Plus Shock Wave Therapy for Traumatic Wounds of the Extremity

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

October 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Walter Reed Army Medical Center

Collaborators

Tissue Regeneration Technologies

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Injuries

Keywords

extracorporeal shock wave therapy, soft tissue wounds

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

213 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Standard of Care Treatment; no study treatment

Arm Title

Standard of Care plus Study Treatment

Arm Type

Experimental

Arm Description

Standard of Care Treatment plus study treatment

Intervention Type

Device

Intervention Name(s)

DermaGold

Intervention Description

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 Measure Information:

Title

Time Frame

90 days following initial treatment

Secondary Outcome Measure Information:

Title

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

Title

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

Title

The number of shock wave treatments performed.

Time Frame

Within six weeks following initial treatment

Title

Time Frame

90 days following initial treatment

Title

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

Title

Durability of wound closure (i.e., status of wound at one month following determination of "healed").

Time Frame

90 days following initial treatment

Title

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

Title

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

Title

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

Title

Length of hospital stay and number of surgical procedures for the extremity wound selected for study

Time Frame

90 days following initial treatment

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tiffany Felix, MS

Phone

251-300-7397

tfelix@hjfresearch.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Stojadinovic, MD

Organizational Affiliation

Walter Reed Army Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reed Army Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20307

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

12846521

Citation

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

Results Reference

background

PubMed Identifier

11400901

Citation

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.

Results Reference

background

PubMed Identifier

11400900

Citation

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.

Results Reference

background

PubMed Identifier

11400872

Citation

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.

Results Reference

background

PubMed Identifier

15629167

Citation

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.

Results Reference

background

PubMed Identifier

2359293

Citation

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.

Results Reference

background

PubMed Identifier

11051007

Citation

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.

Results Reference

background

PubMed Identifier

11084728

Citation

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.

Results Reference

background

PubMed Identifier

15653238

Citation

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.

Results Reference

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

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