Effect of Extracorporeal Shock Waves on Hypertrophy Scar
Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar
1 other identifier
interventional
22
1 country
1
Brief Summary
Assess the effect of extracorporeal shock waves on hypertrophy scar
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 30, 2017
August 1, 2017
2 months
April 19, 2017
August 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline thick of scar
sonography for thick of scar
immediately post intervention, 1 month after, and 3 months
Secondary Outcomes (4)
change from baseline Modified Vancouver Scar Scale
immediately post intervention, 1 month after, and 3 months
change from baseline Visual analogue scores (VAS)
immediately post intervention, 1 month after, and 3 months
change from baseline skin color
immediately post intervention, 1 month after, and 3 months
change from baseline Patient Scar Assessment Scale (POSAS)
immediately post intervention, 1 month after, and 3 months
Study Arms (2)
extracorporeal shock-wave
EXPERIMENTALmassage
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- aged between 18 \~ 65 years old;
- at least 4 weeks since onset of onset of wound;
- healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks
- the most important of all, read and signed the inform concern of this study.
You may not qualify if:
- patients with open wound;
- oxygen dependent
- having evidence of cognitive deficit;
- having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT;
- patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mackay Memorial Hospital
Taipei, 104, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 28, 2017
Study Start
October 1, 2017
Primary Completion
December 1, 2017
Study Completion
June 1, 2019
Last Updated
August 30, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share