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Trial · NCT02460081

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryAnkle-brachial Index (ABI)Approximately 1 yearThe ankle brachial index is the ratio of the measurement of the blood pressure in the ankle and the arm.
PrimaryTranscutaneous oxygen measurement (TCOM)Approximately 1 yearTranscutaneous oxygen measurement measures the oxygen flow in vessels beneath the skin surface
SecondaryAdverse Events (AEs)Approximatly 1 yearNumber of participants with adverse events
SecondaryUlcer closureApproximatly 1 yearUlcer closure is defined as skin closure of the index ulcer without drainage or need for dressing.
SecondaryComplete wound closure of the index ulcerApproximatly 1 yearComplete wound closure is defined as closure of the index ulcer and retaining wound closure for the subsequent 4 weeks.
SecondaryNumber of ulcersApproximatly 1 yearThe total number of non index ulcers will be collected
SecondarySize of ulcersApproximatly 1 yearThe area of each ulcer will be collected.
Secondary50% closure of the index ulcerApproximatly 1 yearThe time to when the ulcer has closed 50 % will be collected.
SecondaryTime to major amputation (above the ankle) of treated legApproximatly 1 yearThe time to a major amputation (above the ankle) will be collected.
SecondaryWagner Grading ScaleApproximatly 1 yearThe extent of the ulcer will be collected using a standard scale for ulcer assessment.
SecondaryRutherford CriteriaApproximately 1 yearThe extent of symptoms associated with decreased limb perfusion will be collected using a standard scale.
SecondaryLeg Rest Pain Score Visual Analog Scale (VAS)Approximately 1 yearPre and Post treatment Limb Pain level will be assessed using a VAS
SecondaryPatient Global Impression of Change in Neuropathy (PGICN)Approximately 1 yearSubjects will be assessed for symptoms of diabetic neuropathy using a standard scale.

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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GET https://conductscience.org/api/trials/v1/NCT02460081/registered