LASER Pilot Project

NCT05966636 | Completed

• 2 other identifiers: A4110-P1I21RX004110-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Veterans who use prosthetic limbs commonly suffer from skin problems such as scars that create discomfort and pain to the point that wearing the prosthesis is no longer tolerable. The Veteran must then discontinue prosthetic use to allow healing prior to wearing the limb again. Current treatments for skin problems include manual scar mobilization and massage, stretching, desensitization techniques, pain medication, prosthetic adjustment, steroid injection, scar excision and others. Most of these have not proven to be a long-term solution. A dermatologic procedure common in non-amputees for scar and skin lesion management, fractionated laser therapy, may be a long-term solution minimizing discomfort, pain and time out of the prosthesis. This preliminary study seeks to determine if fractional laser therapy can improve prosthetic use, and quality of life of Veterans with amputation who use lower limb prostheses.

Conditions

Acquired Absence of Lower Limb; Scar Condition and Fibrosis of the Skin

Keywords

Amputation; Scar; Fractional Ablative Laser Resurfacing

Outcome Measures

Primary Outcomes (9)

• Change in Prosthesis Evaluation Questionnaire

  Patient Reported Outcome Measure with score from 0-100 with increased score demonstrated patient reported improvement

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

• Change in 2 minute walk test

  Functional performance with score from 0 - 999 feet with increased score demonstrating increased velocity in walking

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

• Change in The Patient and Observer Scar Assessment Scale

  Dermatologic Survey on a scale of 1-10 with increased number demonstrating worsening of scar appearance

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

• Change in Optical Coherence Tomography

  Observational Measure for documentation of scar characteristics

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

• Change in Manchester Scar Scale

  Dermatologic survey on a scale of 1-4 with higher numbers representing worsening of conditions of scar

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

• Change in Dermatology Life Quality Index

  Dermatologic survey using a scale from scar problems resulting in very much, a lot, a little or not at all impacts to quality of life

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

• Change in Dermal Torque Meter

  Observational Measure for documentation of scar characteristics

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

• Change in Scar Photography

  Observational Measure for documentation of scar characteristics

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

• Change in Prosthesis Limb User Survey - Mobility

  Patient reported outcome measure with scores from 20-80 with increase in score demonstrating increase in self reported functional mobility

  Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Study Arms (1)

Observational Single Arm

OTHER

All subjects will have scars, quality of life, function assessed pre and post laser treatment

Procedure: Fractional CO2 Laser Ablative Resurfacing

Interventions

Fractional CO2 Laser Ablative Resurfacing PROCEDURE

Fractional lasers stimulate scar improvement through production of microscopic patterns of dermal injury, vaporizing scar tissue and inducing neocollagenesis, subsequently improving scar tissue texture and range of motion, and decreasing symptoms such as pain and pruritis. Current clinical consensus is supportive that fractionated lasers are the most effective option for the treatment of scars. Other laser wavelengths and modalities used for vascular deformities and hair removal for instance, have an adjunctive role in improving scars and may be used in the same laser session. Case reports provide evidence of substantial improvement in sensory symptoms and physical mobility within days to weeks after each treatment.

Observational Single Arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-70 years.
• Lower extremity amputation at the transtibial or transfemoral levels.
• Lower extremity amputee who has regular and compliant use of a lower extremity prosthesis.
• Lower extremity prosthesis use is disrupted or complicated by scarring and other skin maladies treatable with fractional CO2 laser therapy.
• Cognitive ability to understand and willingness to provide informed consent and follow the study protocol.
• Willing and able to attend pre and post procedural assessment sessions.
• Willing and able to attend dermatologic and laser therapy sessions.

You may not qualify if:

• Does not have lower extremity amputation.
• Lower extremity amputee who does not use a prosthesis.
• Lower extremity prosthetic use is not disrupted due to scarring or other skin maladies.
• Residual limb has an open wound or active infection.
• Has any of the following; open residual limb wound, cultured epithelial autographts, active infection, presence of unstable epithelium within the early weeks of injury
• Otherwise not a candidate for laser therapy.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Miami Dermatology and Laser Institute: collaborator
• Bruce W. Carter VA Medical Center: collaborator

Study Sites (2)

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey T Heckman, DO

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Study statistician will be masked
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will perform pre and post assessment of laser treatment techniques to improve scar mobility and skin health in a pilot sample of individuals with lower extremity limb loss who use artificial limbs for mobility.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 28, 2023
• Study Start: February 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)