Trial Outcomes & Findings for High Resolution IR Imaging for Diagnosis in the Acute Limping Child - ThermLimp (NCT NCT03312348)

NCT ID: NCT03312348

Last Updated: 2021-01-22

Results Overview

Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child - 25

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 10 minutes
• Results posted on: 2021-01-22

Participant Flow

Participant milestones

Measure	Infrared Imaging Undertaken Infrared imaging of Region Of Interest in study participants Infrared imaging: Infrared image image acquisition of study participants
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Infrared Imaging Undertaken n=30 Participants Infrared imaging of Region Of Interest in study participants Infrared imaging: Infrared image image acquisition of study participants
Age, Categorical <=18 years	30 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Age, Continuous	5.2 years STANDARD_DEVIATION 3.0 • n=30 Participants
Sex: Female, Male Female	10 Participants n=30 Participants
Sex: Female, Male Male	20 Participants n=30 Participants
Region of Enrollment United Kingdom	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: 10 minutes

Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child - 25

Outcome measures

Measure	Infrared Imaging Undertaken n=30 Participants Infrared imaging of Region Of Interest in study participants Infrared imaging: Infrared image image acquisition of study participants
Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child	30 Participants

Adverse Events

Infrared Imaging Undertaken

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Shammi Ramlakhan - Chief Investigator

Sheffield Children's NHS Trust

Phone: +44 1142262331

Email: shammi.ramlakhan@sch.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place