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

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

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.

Study Overview

• Status: Completed
• Conditions: Limb Volume; Measuring Edema
• Intervention / Treatment: Other: STO3 sensor (Structure Inc., Boulder, CO)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • The RANE Center for Venous and Lymphatic Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The target population will be symptom-free volunteers in order to establish a method of scanning for the best results. Volunteers in this study will have no coercion involved.

Description

Inclusion Criteria:

• The people in this study will be symptom free volunteers.

Exclusion Criteria:

• Pre-existing diseased limbs

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Twenty limbs from ten healthy volunteers	Other: STO3 sensor (Structure Inc., Boulder, CO); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limb Volume	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.	During Procedure

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12. doi: 10.1067/mva.2000.107094.
• Marsocci A, Santandrea S, Lanfranchi E, Donati D, Tedeschi R. Beyond water: 3D laser scanning offers a cutting-edge alternative for upper limb volume assessment. Phlebology. 2024 Dec 19:2683555241310358. doi: 10.1177/02683555241310358. Online ahead of print.
• Raju S, Owen S Jr, Neglen P. Reversal of abnormal lymphoscintigraphy after placement of venous stents for correction of associated venous obstruction. J Vasc Surg. 2001 Nov;34(5):779-84. doi: 10.1067/mva.2001.119396.
• Katz ML, Comerota AJ, Kerr RP, Caputo GC. Variability of venous-hemodynamics with daily activity. J Vasc Surg. 1994 Feb;19(2):361-5. doi: 10.1016/s0741-5214(94)70111-3.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: lymphedema; Leg swelling; 3-D Volumetry; phlebolymphedema; CEAP Clinical Class 3; Limb plethysmography
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: 2024-008-St. Dom

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The consent form clearly states that "We will not collect any protected health information in this study. Data collected will be as following: sex, age, weight, and volume of limbs." Therefore, there is no risk to patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No