Clinical trial NCT06944041: Measuring Volume Using a 3D Scanner and iPad to Grade the Swelling of Legs
Official title: Limb Volumetry Using iPad Based 3D Scanner for Assessment of Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb Volume
Measuring Edema
Keywords: Leg swelling
3-D Volumetry
phlebolymphedema
CEAP Clinical Class 3
Limb plethysmography
lymphedema
Lead sponsor: The RANE Center for Venous and Lymphatic Diseases at St. Dominic's Hospital
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pre-existing diseased limbs

Primary outcomes:
measure: Limb Volume
timeFrame: During Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: The RANE Center for Venous and Lymphatic Diseases
state: Mississippi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.