Trial · NCT07536373
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amputation-free survival | 12 months | Defined as the time to major (above the ankle) amputation of the study limb or death from any cause |
| Secondary | Number of Participants with Major (Above the Ankle) Non-Traumatic Amputation of the Study Limb | 12 months | Number of participants who underwent major (above the ankle) non-traumatic amputation of the study limb during the 12-month follow-up period. |
| Secondary | Major adverse limb event (MALE, including non-traumatic above-ankle amputation and major lower limb artery reintervention) and its components | 12 months | |
| Secondary | Major adverse cardiovascular event (MACE, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) and its components | 12 months | |
| Secondary | Wound healing rates at 3, 6, 9 and 12 months for Rutherford 5 patients (or time to wound healing) | 12 months | |
| Secondary | Number of Participants with Acute Limb Ischemia | 12 months | Number of participants experiencing acute limb ischemia of the study limb during the 12-month follow-up period, adjudicated by a blinded clinical events committee. |
| Secondary | Number of Deaths from Any Cause | 12 months | Number of participants who died from any cause during the 12-month follow-up period. |
| Secondary | Number of Deaths from Cardiovascular Causes | 12 months | Number of participants who died from cardiovascular causes during the 12-month follow-up period, adjudicated by a blinded clinical events committee. |
| Secondary | Number of Deaths from Limb-Related Causes | 12 months | Number of participants who died from limb-related causes (e.g., fatal limb sepsis, complications of major amputation) during the 12-month follow-up period. |
| Secondary | Number of Participants with Adverse Gastrointestinal Events | 12 months | Number of participants experiencing adverse gastrointestinal events (including nausea, vomiting, abdominal pain, and diarrhea) during the 12-month treatment period. |
| Secondary | Number of Participants with Adverse Hematologic Events | 12 months | Number of participants experiencing adverse hematologic events (including leukopenia, thrombocytopenia, and anemia) during the 12-month treatment period. |
| Secondary | Number of Participants with Serious Infections | 12 months | Number of participants experiencing serious infections (defined as infections requiring hospitalization or intravenous antibiotics) during the 12-month follow-up period. |
| Secondary | Number of Participants with Diarrhea | 12 months | Number of participants experiencing diarrhea as an adverse event during the 12-month treatment period. Diarrhea is defined as the passage of three or more loose or watery stools within a 24-hour period, and severity is graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 = increase of \<4 stools/day over baseline; Grade 2 = increase of 4-6 stools/day; Grade 3 = increase of ≥7 stools/day or hospitalization indicated; Grade 4 = life-threatening consequences; Grade 5 = death. |
| Secondary | Number of Participants with Drug Discontinuation Due to Any Adverse Event | 12 months | Number of participants who permanently discontinued the study drug due to any adverse event during the 12-month treatment period. |
| Secondary | Change in Health-Related Quality of Life as Measured by the EQ-5D-5L Index Score | Baseline and 12 months | Change from baseline in EQ-5D-5L index score at 12 months. The EQ-5D-5L is a generic health status questionnaire. Index scores range from -0.6 to 1.0, where higher scores indicate better health-related quality of life. |
| Secondary | Change in Disease-Specific Quality of Life as Measured by the VASCUQOL-6 Score | Baseline and 12 months | Change from baseline in Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) summary score at 12 months. VASCUQOL-6 scores range from 6 to 24, where higher scores indicate better vascular disease-specific quality of life. |
| Secondary | Change in Walking Ability as Measured by the Walking Impairment Questionnaire (WIQ) Score | Baseline and 12 months | Change from baseline in Walking Impairment Questionnaire (WIQ) composite score at 12 months. The WIQ assesses walking distance, walking speed, and stair climbing. Each domain is scored from 0 to 100, where higher scores indicate better walking ability. |
| Secondary | Change in Ankle-Brachial Index (ABI) | Baseline and 12 months | Change from baseline in ankle-brachial index (ABI) of the study limb at 12 months. ABI is calculated as the ratio of ankle systolic blood pressure to brachial systolic blood pressure (unitless ratio). Higher values indicate better lower-extremity arterial perfusion. |
| Secondary | Change in Toe-Brachial Index (TBI) | Baseline and 12 months | Change from baseline in toe-brachial index (TBI) of the study limb at 12 months. TBI is calculated as the ratio of toe systolic blood pressure to brachial systolic blood pressure (unitless ratio). Higher values indicate better distal perfusion. |
| Secondary | Change in Transcutaneous Oxygen Pressure (TcPO2) | Baseline and 12 months | Change from baseline in transcutaneous oxygen pressure (TcPO2) of the study limb at 12 months, measured in mmHg. Higher values indicate better tissue oxygenation. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07536373/registered