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Effect of Extracorporeal Shock Waves on Hypertrophy Scar

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ClinicalTrials.gov Identifier: NCT03134053
Recruitment Status : Not yet recruiting
First Posted : April 28, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Li-Ru Chen,MD, Mackay Memorial Hospital

Brief Summary:
Assess the effect of extracorporeal shock waves on hypertrophy scar

Condition or disease Intervention/treatment Phase
Hypertrophy; Scar Device: extracorporeal shock-wave Other: massage Not Applicable

Detailed Description:

Prolonged and abnormal scarring after trauma, burns and surgical procedures often results in functional and cosmetic deformities. A wide variety of treatments have been advocated for pathologic scars regression. Unfortunately, the reported efficacy has been variable.Unfocused extracorporeal shock wave therapy is a feasible and non-intensive treatment. And it is an emerging option for the treatment of painful and retracting scars.

Administration of ESWT appears to result in significant improvements in scar clinical appearance, mobility and subjective pain. Clinical data were mirrored by histologic changes in connective tissue appearance and scar vascularization. Extracorporeal shock wave therapy is also an effective and conservative treatment for patients with aesthetic and functional sequela from burn scars. It is a feasible, cost-effective, well-tolerated treatment that can be used in the management of post-burn pathologic scars after the patients are briefed on the practical aspects of the treatment procedure.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars Shock

Arm Intervention/treatment
Experimental: extracorporeal shock-wave Device: extracorporeal shock-wave
to treat painful and retracting scars

Sham Comparator: massage Other: massage
to treat painful and retracting scars




Primary Outcome Measures :
  1. change from baseline thick of scar [ Time Frame: immediately post intervention, 1 month after, and 3 months ]
    sonography for thick of scar


Secondary Outcome Measures :
  1. change from baseline Modified Vancouver Scar Scale [ Time Frame: immediately post intervention, 1 month after, and 3 months ]
    questionnaires of Modified Vancouver Scar Scale for scar measure

  2. change from baseline Visual analogue scores (VAS) [ Time Frame: immediately post intervention, 1 month after, and 3 months ]
    Visual analogue scores (VAS) for pain

  3. change from baseline skin color [ Time Frame: immediately post intervention, 1 month after, and 3 months ]
    DermaLab Combo series for skin color

  4. change from baseline Patient Scar Assessment Scale (POSAS) [ Time Frame: immediately post intervention, 1 month after, and 3 months ]
    questionnaires of Patient Scar Assessment Scale (POSAS) for scar measure



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged between 18 ~ 65 years old;
  2. at least 4 weeks since onset of onset of wound;
  3. healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks
  4. the most important of all, read and signed the inform concern of this study.

Exclusion Criteria:

  1. patients with open wound;
  2. oxygen dependent
  3. having evidence of cognitive deficit;
  4. having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT;
  5. patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134053


Contacts
Contact: Li-Ru Chen, MD 886-2-2543-3535 gracealex168@gmail.com

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 104
Contact: Li-Ru Chen, MD       gracealex168@gmail.com   
Principal Investigator: Li-Ru Chen, MD         
Sponsors and Collaborators
Mackay Memorial Hospital

Responsible Party: Li-Ru Chen,MD, MD, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03134053     History of Changes
Other Study ID Numbers: 16MMHIS025e
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Li-Ru Chen,MD, Mackay Memorial Hospital:
hypertrophy scar
burn

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Cicatrix
Fibrosis
Pathologic Processes