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Trial · NCT02600390

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySafety of treatment as determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events8 or 10 weeks
PrimaryChange in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale, relative to non-wound site pain scores8 or 10 weeks
PrimaryRate and extent of leg ulcer wound healing as measured by change in wound surface area8 or 10 weeks
SecondaryChanges in leg ulcer wound status as measured by need for debridement (type and quantity of non-viable tissue)8 or 10 weeks
SecondaryChanges in leg ulcer wound status as measured by extent of exudate production8 or 10 weeksChange in quality of life as measured by SF-12 Health Survey (acute version) as well as other indicators of patient comfort and well-being
SecondaryChanges in leg ulcer wound status as measured by type and amount of granulation tissue8 or 10 weeks
SecondaryChanges in leg ulcer wound status as measured by overall change in leg ulcer wound appearance8 or 10 weeks
SecondaryChange in local skin in the region of the leg ulcer as measured by skin appearance (coloration, inflammation, etc.)8 or 10 weeks
SecondaryChange in local skin in the region of the leg ulcer as measured by skin temperature (relative to body temperature)8 or 10 weeks
SecondaryImprovement in leg ulcer wound severity as measured by Venous Clinical Severity Score (VCSS)8 or 10 weeks
SecondaryChange in quality of life, as measured by an SF-12 Health Survey (acute version) as well as other indicators of patient comfort and well-being8 or 10 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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