Socket Cooling Effectiveness Take Home Study

NCT04484805 | Completed Results FDA Device

• 2 other identifiers: 120180039W81XW-17-C-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.

Conditions

Amputation; Amputation; Traumatic, Leg, Lower; Amputation Stump; Limb; Absence, Congenital, Lower; Prosthesis User; Lower Limb Amputation Below Knee (Injury)

Keywords

cooling; amputee; lower limb absence; prosthesis; prosthetic leg; transtibial; below knee amputation; lower limb difference; lower limb loss; socket; prosthetist; sweat; active; walking; prosthetic liner; prosthetic sock; perspiration; moisture; heat; thermal

Outcome Measures

Primary Outcomes (1)

• Residual Limb Temperature

  This will be tested only during in-lab visits. An intervention of the experimental socket with the ICE cooling unit should yield at least a 2 degree Celsius decrease in temperature compared with no intervention. This will be tested in-lab with 6 thermocouples taped to the residual limb while the subject is sitting and walking on a treadmill. The reported result is the temperature difference of the residual limb from the baseline temperature (before activity) to the end of the sitting period (after activity). The ICE or Sham unit is turned on 5 minutes before the 15 minute walking period. After the 15 minute walking period, the participant sits with the unit ON for 45 minutes. The baseline temperature reading is taken directly before the unit is turned on, and the end temperature reading is taken after the 45 minutes of sitting.

  4 hours

Study Arms (2)

ICE Unit

EXPERIMENTAL

The subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.

Device: ICE Condition

Sham Unit

SHAM COMPARATOR

The subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.

Device: Sham Condition

Interventions

ICE Condition DEVICE

Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.

Also known as: Cooling Unit, ICE Unit

ICE Unit

Sham Condition DEVICE

Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.

Also known as: Sham Unit

Sham Unit

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a lower limb absence
• Willing and able to complete outlined tasks
• Must complete and pass our Semmes-Weinstein monofilament test
• Must understand English in order to be properly consented and provide feedback to the study personnel

You may not qualify if:

• The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study
• No symptoms consistent with peripheral neuropathy or other sensory diagnosis that could prevent them from feeling the temperature of their limb

Sponsors & Collaborators

• Liberating Technologies, Inc.: lead
• Vivonics, Inc.: collaborator

Study Sites (2)

Liberating Technologies, Inc.

Holliston, Massachusetts, 01746, United States

Location

Minneapolis VA

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Todd Farrell
• Organization: Liberating Technologies, Inc.

todd.farrell@liberatingtech.com

774-233-0873

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: July 24, 2020
• Study Start: August 1, 2019
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: October 22, 2024
• Results First Posted: October 22, 2024

Record last verified: 2024-10

Locations

US (2)