N/A
N=16
Heat Therapy to Reduce Pain and Improve Walking Tolerance
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT03435835 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Peak Walking Time — 955.6; 947.7 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control/Sham Treatment (Device); Heat Therapy (HT) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Walking Time |
955.6; 947.7 | — |
| SECONDARY Claudication Onset Time |
452.6; 442.9 | — |
| SECONDARY Peak Systolic Blood Pressure |
193.3; 189.3 | — |
| SECONDARY Peak Diastolic Blood Pressure |
74.2; 73.5 | — |
| SECONDARY Peak Calf Tissue Saturation Index |
43.9; 43.1 | — |
| SECONDARY Post-exercise Plasma Endothelin-1 Concentration |
2.0; 1.7 | — |
Summary
The purpose of this study is to investigate whether exposure to heat therapy improves calf muscle oxygenation and enhances walking tolerance in patients with symptomatic Peripheral Arterial Disease (PAD).
Eligibility Criteria
Inclusion Criteria
- Men and women with stable symptomatic leg claudication for 6 months or longer.
- Ankle brachial index 36 or unable to fit in water-circulating pants
- Open wounds or ulcers on the extremity
- Unable to walk on the treadmill
Data sourced from ClinicalTrials.gov (NCT03435835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.