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The TEMPAD study

The effect of foot skin temperature on microcirculation measurements in patients with peripheral artery disease - The TEMPAD study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61208
Enrollment
51
Registered
2026-03-25
Start date
2026-08-03
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral artery disease (PAD) Blockage of leg arteries

Interventions

All participants will undergo controlled modulation of foot skin temperature within a clinically feasible range (26-31°C). Microcirculatory measurements (TcPO2, LSCI and SPP) will be performed under t

Sponsors

Ziekenhuis Groep Twente (ZGT)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: >18 yearsWilling to give written informed consent (IC) PAD stage Fontaine 2 (2a or 2b)

Exclusion criteria

Exclusion criteria: Amputation of (part of) the lower extremitiesPresence of wounds or other skin lesions on the foot (e.g. ulcers, blisters, or other forms of skin damage)Severe callusSevere cold sensitivity (e.g. Raynaud’s syndrome)Oedema or infection of (part of) the lower extremitiesSevere or unstable heart failure (NYHA class III–IV or recent decompensation)

Design outcomes

Primary

MeasureTime frame
The primary study parameters are the within-subject differences and between-subject variability in TcPO2, LSCI, and SPP measurements, measured under cold and warm conditions.

Secondary

MeasureTime frame
The secondary study parameters are the within-subject differences and between-subject variability in TcPO2, LSCI, and SPP measurements in the subgroups with and without peripheral neuropathy and with and without diabetes.

Countries

Netherlands

Contacts

Public ContactK.D.R. Kappert

Ziekenhuis Groep Twente (ZGT)

k.kappert@zgt.nl0657915596

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026