Measuring Volume Using a 3D Scanner and iPad to Grade the Swelling of Legs

We used a new and easy-to-measure iPad 3D scanner to measure swelling in lower limbs because current technology is not easily available or affordable. We want to see how reliable the measurements are and what might affect how consistent they are.

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Key information

Conditions

Limb Volume Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Measuring Edema

Sex eligibility

All sexes

Study type

Observational

Primary location

The RANE Center for Venous and Lymphatic Diseases

Jackson, Mississippi, 39216, United States

About this study

Twenty limbs from ten healthy volunteers were scanned using an iPad-based Structure Sensor and software. Initial scans followed standard manufacturer instructions, but high variance rendered data unsuitable for clinical use. To improve accuracy, a standardized scanning protocol was developed, incorporating anatomical calibration, scanning distance standardization, and scanning time control. A 254-mm calf segment was defined using a 3D marker placed on the medial malleolus to ensure consistent volume measurement. The scanning distance was fixed between 50-59 cm to reduce zoom parallax errors, and scans were conducted after 3 PM to minimize diurnal volume fluctuations. Multiple technicians performed repeat scans on the same limb to assess intra-observer and inter-observer scan reliability.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The people in this study will be symptom free volunteers.

Exclusion criteria

Pre-existing diseased limbs

Treatment and study plan

STO3 sensor (Structure Inc., Boulder, CO)

Other

The advent of Apple iPad based 3D scanner opens a new avenue for measuring limb volume. The latest ambient light scanner model was utilized for the current study. 3D scanning technology has gained broad industrial use, including the manufacturing of high-precision tools. A commercially available software package was used for limb volumetry.

Primary outcomes

Limb Volume

Time frame: During Procedure

The scanning protocol and the required modifications of "out of the box" instructions for optimal clinical application are described; The 10 inch (254mm) long limb segment scanned must be anatomically constant. We chose the medial malleolus as the lower border of the scan. The scannable limb volume is 254 mm long, measured up from the malleolus.

Sponsors and collaborators

Lead sponsor

The RANE Center for Venous and Lymphatic Diseases at St. Dominic's Hospital

Other

Registry information

Official study title

Limb Volumetry Using iPad Based 3D Scanner for Assessment of Edema

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Apr 25, 2025
Registry last updated: May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed