Activity Reduction vs Advice for Plantar Hotspots in Diabetes
A legfontosabb adatok
- Ki végzi
- Shifa International Hospital
- Hol
- Pakisztán1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 100 fő, tervezett
- Kezdés
- 2026. okt. 1.
- Várható befejezés
- 2027. ápr. 28.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Individualized Objectively Monitored Activity Reduction
- Standard Activity-Reduction Advice
- A regiszteradat frissítve
- 2026. szeptember 25.
Ki vehet részt
- Életkor
- 18 év – 80 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 26 feltétel megnézéseKevesebb
Ki vehet részt
- Age ≥18 years
- Type 1 or type 2 diabetes mellitus
- Loss of protective sensation demonstrated by standardized 10-g monofilament testing
- IWGDF risk category 3
- Previous diabetic foot ulceration and/or lower-extremity amputation consistent with IWGDF risk category 3
- Any previous ulcer on the relevant foot completely epithelialized and clinically healed for at least 4 weeks
- Confirmed plantar thermal hotspot, defined as an inter-foot temperature difference >2.2°C at the same anatomically comparable plantar site on two consecutive days
- Intact skin at the index hotspot
- Community ambulatory
- Able to perform daily foot-temperature measurements independently or with caregiver assistance
- Able to reduce ambulatory activity temporarily if assigned to the experimental intervention
- At least five valid days of objectively recorded daily step-count data during Days -21 through -3 relative to the first positive thermal screening measurement
- Objective historical activity data available from a smartphone, smartwatch, activity tracker, pedometer with stored daily counts, or another verifiable device-based source
- Willing to continue objective activity measurement during randomized follow-up whenever technically possible
- Able to provide informed consent and complete study procedures
Ki nem vehet részt
- Recent acute foot trauma or surgery that could independently alter local foot temperature
- Active diabetic foot ulcer or other open foot wound
- Clinical evidence of foot infection
- Critical limb-threatening ischaemia or another vascular condition requiring urgent management
- Medical condition for which substantial temporary reduction in ambulatory activity would be unsafe
- Cognitive or functional impairment preventing study procedures without suitable caregiver assistance
- Blister, hemorrhagic callus, skin breakdown, or another pre-ulcerative lesion requiring immediate therapeutic management
- Active or suspected Charcot neuro-osteoarthropathy
- Predominantly non-ambulatory or wheelchair-dependent status
- Inability to provide the required pre-hotspot objective activity history
- Absence of an anatomically valid contralateral comparison site for the proposed index hotspot
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 80 év között vagy?
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
This randomized proof-of-concept trial will evaluate whether an individualized, objectively monitored temporary reduction in walking activity can accelerate resolution of plantar thermal hotspots in adults with diabetes who are at high risk of foot ulceration. A plantar thermal hotspot is defined as a temperature difference greater than 2.2°C between corresponding sites on the two feet on two consecutive days.
A teljes eredeti leírásKevesebb
Participants with a confirmed eligible hotspot will be randomly assigned to either an individualized numerical daily step-count target or standard non-quantified advice to reduce walking and weight-bearing activity. Both groups will receive standard diabetic-foot preventive care, daily foot-temperature monitoring, and objective activity monitoring.
The primary outcome is the time from randomization to sustained resolution of the index plantar thermal hotspot during the first 14 days. Participants will be followed for 28 days to assess hotspot recurrence, foot-related outcomes, safety, and acceptability.
A vizsgálat 2 csoportja
- Individualized Objectively Monitored Activity ReductionA vizsgált kezelés
Participants will receive standard diabetic-foot preventive care, daily plantar-temperature monitoring, and objective step-count recording, plus an individualized temporary daily step-count target. The default target will be no more than 50% of the participant's objectively recorded habitual daily activity. If a 50% reduction is judged clinically inappropriate, a prespecified modified target requiring at least a 25% reduction may be used. Participants will receive feedback comparing their recorded activity with the prescribed target and will continue the temporary activity restriction until sustained hotspot resolution.
- Standard Activity-Reduction AdviceMár használt kezelés, összehasonlításként
Participants will receive the same standard diabetic-foot preventive care, daily plantar-temperature monitoring, and objective step-count recording as the experimental group. They will receive standardized written and verbal advice to substantially reduce unnecessary walking and weight-bearing activity while the hotspot remains present. They will not receive an individualized numerical step-count target, percentage activity target, structured feedback comparing actual activity with a target, or escalation of the activity prescription solely because a numerical target was not achieved.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Objectively Monitored Individualized Activity Reduction Versus Standard Advice for Resolution of Plantar Thermal Hotspots in Adults With Diabetes: A Randomized Controlled Trial
- Illeszkedési kérdések
- Forrás: NCT07840300: ki vehet részt
- A regiszteradat frissítve
- 2026. szeptember 25.