Soft Tissue InjuriesPhase 3CWINCT00486733
Study to Determine if Shock Wave Therapy Applied to Traumatic Wounds of the Extremity Improves Healing Time
A Phase 3 study testing DermaGold in people with Soft Tissue Injuries, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- DermaGold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: Prospective Randomized Trial of Standard Wound Care Versus Standard Wound Care Plus Shock Wave Therapy for Traumatic Wounds of the Extremity
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.
Read the 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.
- Conditions
- Soft Tissue Injuries
- Being tested
- DermaGold
- Keywords
- extracorporeal shock wave therapy, soft tissue wounds
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaGoldDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: DermaGold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 90 days following intitial treatment
The number of shock wave treatments performed.
Measured: 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.
Measured: 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").
Measured: 28 days following inititial treatment
Durability of wound closure (i.e., status of wound at one month following determination of "healed").
Measured: 90 days following initial treatment
Serial wound punch biopsies for quantitative bacterial cultures, bacterial 16sRNA, and molecular analysis of 185 relevant wound healing genes.
Measured: 28 days following intitial treatment
Serum from venous blood and Vacuum Assisted Wound Closure Device (VAWCD) effluent for biomarkers, C-reactive protein, and cortisol levels.
Measured: 28 days following initial treatment
Mean wound surface area, circumference, depth and estimated volumes over time, ESWT group versus control group, as determined by CDM planimetry surface measurements.
Measured: 90 days following initial treatment
Length of hospital stay and number of surgical procedures for the extremity wound selected for study
Measured: 90 days following initial treatment
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).
Measured: 90 days following intitial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Tissue Regeneration Technologies
- Responsible party
- Principal investigator, Alexander Stojadinovic, Walter Reed National Military Medical Center
- Investigators
- Alexander Stojadinovic, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486733
- Sponsor's protocol ID
- 06-20028
- Acronym
- CWI
- Status last verified
- Dec 2012
- First submitted
- 13 Jun 2007
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.
PubMed 12846521Wang 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.
PubMed 11400901Schaden 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.
PubMed 11400900Ludwig 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.
PubMed 11400872Meirer 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.
PubMed 15629167Haupt 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.
PubMed 2359293Ludwig 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.
PubMed 11051007Lauber 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.
PubMed 11084728Gerdesmeyer 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.
PubMed 15653238
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Standard Wound Care Versus Standard Wound Care Plus Shock Wave Therapy for Traumatic Wounds of the Extremity
- ClinicalTrials.gov ID
- NCT00486733
- Acronym / sponsor ID
- CWI / 06-20028
- Conditions
- Soft Tissue Injuries
- Keywords
- extracorporeal shock wave therapy, soft tissue wounds
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- Tissue Regeneration Technologies
- Study start
- Apr 2007
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of Care Treatment; no study treatment |
| Standard of Care plus Study Treatment | Experimental | Device: DermaGoldStandard of Care Treatment plus study treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermaGoldThe 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. | Device | Standard of Care plus Study Treatment |
Primary outcome
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
11 secondary outcomes
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
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
The number of shock wave treatments performed.
Time frame: 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.
Time frame: 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").
Time frame: 28 days following inititial treatment
Durability of wound closure (i.e., status of wound at one month following determination of "healed").
Time frame: 90 days following initial treatment
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
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
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
Length of hospital stay and number of surgical procedures for the extremity wound selected for study
Time frame: 90 days following initial treatment
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- Background: PubMed 12846521Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.
- Background: PubMed 11400901Wang 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.
- Background: PubMed 11400900Schaden 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.
- Background: PubMed 11400872Ludwig 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.
- Background: PubMed 15629167Meirer 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.
- Background: PubMed 2359293Haupt 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.
- Background: PubMed 11051007Ludwig 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.
- Background: PubMed 11084728Lauber 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.
- Background: PubMed 15653238Gerdesmeyer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Stojadinovic, MD principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DermaGold in people with Soft Tissue Injuries, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Felix, MS (251-300-7397, tfelix@hjfresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00486733, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.