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Standard of Care plus Study Treatment for Soft Tissue Injury (CWI Trial)

Phase 3
Waitlist Available
Led By Alexander Stojadinovic, MD
Research Sponsored by Walter Reed Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days following initial treatment
Awards & highlights

CWI 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.

CWI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days following initial treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days following initial treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
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).
Durability of wound closure (i.e., status of wound at one month following determination of "healed").
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.
+8 more

CWI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care plus Study TreatmentExperimental Treatment1 Intervention
Standard of Care Treatment plus study treatment
Group II: Standard of CareActive Control1 Intervention
Standard of Care Treatment; no study treatment

Find a Location

Who is running the clinical trial?

Walter Reed Army Medical CenterLead Sponsor
69 Previous Clinical Trials
20,726 Total Patients Enrolled
Tissue Regeneration TechnologiesIndustry Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Alexander Stojadinovic, MDPrincipal InvestigatorWalter Reed Army Medical Center
2 Previous Clinical Trials
540 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Determine if Shock Wave Therapy Applied to Traumatic Wounds of the Extremity Improves Healing Time
Alexander Stojadinovic 2007. "Study to Determine if Shock Wave Therapy Applied to Traumatic Wounds of the Extremity Improves Healing Time". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00486733.
All > Trauma
~12 spots leftby May 2025
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