Laser Therapy for Scarring and Fibrosis in Amputees

(LASER Trial)

Recruiting at 1 trial location

Overseen By Meghan E Kern, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: No amputation, No prosthesis use, Open wound, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fractional CO2 Laser Ablative Resurfacing for scarring and fibrosis in amputees?

Research shows that Fractional CO2 Laser Ablative Resurfacing is effective in treating various types of scars, including burn scars and surgical scars, by improving their appearance and reducing tension. This suggests it could also be beneficial for scarring and fibrosis in amputees. ^{1 2 3 4 5}

Is laser therapy for scarring and fibrosis in amputees generally safe?

Fractional CO2 laser therapy, used for skin resurfacing and scar treatment, generally has an improved safety profile compared to traditional methods, with faster healing and reduced downtime. However, some side effects like scarring, skin color changes, and rare reactions have been reported, so it's important to discuss potential risks with a healthcare provider. ^{6 7 8 9 10}

How does laser therapy for scarring and fibrosis in amputees differ from other treatments?

This laser therapy uses fractional CO2 technology, which is unique because it can be customized to each patient's skin and provides controlled thermal damage to improve scar tissue. Unlike other treatments, it can immediately relax tension in scars and activate a molecular response for long-term improvements. ^{1 4 11 12 13}

What is the purpose of this trial?

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.

Research Team

Jeffrey T Heckman, DO

Principal Investigator

James A. Haley Veterans' Hospital, Tampa, FL

Eligibility Criteria

This trial is for Veterans aged 21-70 with lower limb amputations who regularly use prostheses but experience discomfort due to scarring. Participants must understand the study, attend sessions, and have skin issues treatable by laser therapy. Those without prosthesis-related skin problems or with open wounds/infections are excluded.

Inclusion Criteria

I am between 21 and 70 years old.

I can attend all required assessment sessions before and after the procedure.

Regular and compliant use of a lower extremity prosthesis

Exclusion Criteria

I am not eligible for laser therapy.

Does not have lower extremity amputation

Lower extremity amputee who does not use a prosthesis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedural Assessment

Participants undergo pre-procedural assessment including subjective and objective measures to evaluate functional mobility, socket comfort, prosthetic history, health-related quality of life, and residual limb measures.

1-2 weeks

Treatment

Participants receive fractionated CO2 laser therapy from a credentialed dermatologist.

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits to repeat outcome measures.

6 months

3 visits (in-person) at 6 weeks, 3 months, and 6 months

Treatment Details

Interventions

• Fractional CO2 Laser Ablative Resurfacing

Trial Overview The LASER Pilot Project tests whether fractional CO2 laser ablative resurfacing can help Veterans with amputations improve their comfort and quality of life when using lower limb prostheses by managing scars and other skin issues.

Participant Groups

Group I: Observational Single Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Miami Dermatology and Laser Institute

Collaborator

Trials

3

Recruited

70+

Bruce W. Carter VA Medical Center

Collaborator

Trials

1

Recruited

20+

Findings from Research

A multicenter study involving 29 subjects with hypertrophic burn scars demonstrated that fractional ablative CO2 laser treatment significantly improved the elasticity, thickness, and overall appearance of scars, with objective measures showing improvements at a statistically significant level (P < 0.01).

Patient-reported outcomes also indicated significant reductions in pain and pruritus, and these improvements were sustained for at least 6 months after the treatment, highlighting the efficacy and lasting benefits of this laser therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Miletta, N., Siwy, K., Hivnor, C., et al.[2022]

A retrospective study of 490 fractional CO2 laser treatments in 374 patients showed that this method has a low incidence of adverse events (13.6%), making it a safe option for treating skin issues like wrinkles and scars.

The most common side effects included acneiform eruptions and herpes simplex outbreaks, but there were no reports of scarring or hypopigmentation, indicating a favorable safety profile compared to traditional laser treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adverse events of deep fractional CO(2): a retrospective study of 490 treatments in 374 patients. Shamsaldeen, O., Peterson, JD., Goldman, MP.[2011]

In a study of 24 female patients undergoing three fractional CO2-laser treatments, patient satisfaction with skin appearance significantly improved after treatment, exceeding their initial high expectations.

Despite no direct correlation between measured wrinkle reduction and patient satisfaction, the treatment led to enhanced skin-related quality of life and self-esteem, making it a recommended option for those seeking to improve photoaged skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional carbon dioxide laser resurfacing of rhytides and photoaged skin--a prospective clinical study on patient expectation and satisfaction. Kohl, E., Meierhöfer, J., Koller, M., et al.[2015]

Fractional CO2 laser procedures are safe and effective for skin rejuvenation and scar management, allowing for customized treatments based on individual skin features.

Very short-pulse-duration devices can provide significant improvements in scar tissue by inducing controlled thermal damage, leading to immediate relaxation of tension and long-term skin remodeling through molecular activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Developments for Fractional Co2 Resurfacing for Skin Rejuvenation and Scar Reduction. Clementoni, MT., Pedrelli, V., Zaccaria, G., et al.[2020]

A single session of 10,600 nm CO2 fractional laser treatment applied early after surgery did not show a statistically significant improvement in objective scar grading (Vancouver Scar Scale) compared to untreated scars, indicating that the laser may not enhance scar healing in a measurable way.

However, patients reported a significant preference for the laser-treated scars over the untreated ones, suggesting that while objective measures may not show improvement, subjective satisfaction with scar appearance is enhanced by early laser treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative single treatment ablative fractional lasing of Mohs micrographic surgery facial scars: a split-scar, evaluator-blinded study. Sobanko, JF., Vachiramon, V., Rattanaumpawan, P., et al.[2015]

In a study of 46 patients treated with fractional CO₂ laser therapy, the average duration of side effects like erythema and scabs was 5.2 days and 4.1 days, respectively, with moderate pain levels reported (3.3/10 for premedicated patients and 4.1/10 for non-premedicated patients).

Complications occurred in 21.7% of treatments, including facial herpes and inflammatory reactions, highlighting the need for antiviral prophylaxis (valacyclovir) for all patients to mitigate risks, although all complications resolved quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CO₂ fractional resurfacing: side effects and immediate complications]. Naouri, M., Delage, M., Khallouf, R., et al.[2011]

Fractionated CO(2) lasers are effective for skin resurfacing, particularly in treating facial photoaging and scars.

These lasers offer a better safety and recovery profile compared to traditional CO(2) laser treatments, making them a preferable option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional CO(2) laser resurfacing. Carniol, PJ., Harirchian, S., Kelly, E.[2017]

Ultrapulsed CO2 laser therapy, while effective for treating scars, can lead to unique complications in patients with a history of silver-impregnated dressings, such as worsening hyperpigmentation and the development of pseudo-ochronotic fibers.

A biopsy after treatment revealed dystrophic calcification associated with the laser treatment, indicating that prior silver exposure may influence the outcomes of CO2 laser therapy, highlighting the need for careful patient history assessment before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dystrophic calcification and accentuated localized Argyria after fractionated carbon dioxide laser therapy of hypertrophic scars. Shaub, AR., Brown, PJ., Kobayashi, TT., et al.[2016]

Despite advancements in technology, including the use of fractionated CO2 laser resurfacing, patients may still experience adverse effects similar to those from traditional CO2 laser treatments, such as scarring and hypopigmentation.

A case study of a 55-year-old female revealed these side effects occurred just 9 days after undergoing fractionated ablative CO2 laser resurfacing, highlighting the need for continued evaluation of safety in new laser technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scarring and persistent erythema after fractionated ablative CO2 laser resurfacing. Ross, RB., Spencer, J.[2022]

A new microablative CO2 laser for skin resurfacing has been shown to be safe and effective, providing over 50% improvement in skin conditions like wrinkles and acne scars in a study of 32 patients followed for at least 6 months.

The fractional photothermolysis technique allows for quicker healing and less downtime compared to traditional fully ablative CO2 lasers, with patients reporting high satisfaction, especially those treated for wrinkles and sun damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablative skin resurfacing with a novel microablative CO2 laser. Gotkin, RH., Sarnoff, DS., Cannarozzo, G., et al.[2015]

In a study involving 20 patients with post-surgical scars, fractionated Er:YAG laser resurfacing showed a statistically significant superior outcome compared to fully ablative Er:YAG, with physician assessments indicating a 32.5% improvement and patient assessments showing a 58.1% improvement in scar appearance.

Patients preferred the fractionated Er:YAG laser treatment (94% preference) and reported no significant difference in pain levels between the two laser types, suggesting that fractionated lasers may offer better results with similar comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated Er:YAG laser versus fully ablative Er:YAG laser for scar revision: Results of a split scar, double blinded, prospective trial. Tidwell, WJ., Owen, CE., Kulp-Shorten, C., et al.[2018]

A study involving 20 patients demonstrated that fractional CO2 laser treatments for acne scars showed no significant difference in effectiveness between different fluences and densities, suggesting flexibility in treatment options.

However, higher fluences and densities were associated with more adverse effects, indicating that using lower settings may provide effective results with fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison study of fractional carbon dioxide laser resurfacing using different fluences and densities for acne scars in Asians: a randomized split-face trial. Yuan, XH., Zhong, SX., Li, SS.[2022]

Ablative fractional photothermolysis using a CO2 laser is effective and safe for treating photo-damaged skin on the neck, with lower energy settings (50 and 100 mJ) causing less thermal damage and inflammation compared to higher settings (300 mJ).

Higher energy settings (300 mJ) can lead to prolonged dermal remodeling and granuloma formation, indicating a need for at least 4 weeks between treatment sessions to allow for proper healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo wound healing and dermal matrix remodelling in response to fractional CO(2) laser intervention: clinicopathological correlation in non-facial skin. Grunewald, S., Bodendorf, M., Illes, M., et al.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The adverse events of deep fractional CO(2): a retrospective study of 490 treatments in 374 patients. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Fractional carbon dioxide laser resurfacing of rhytides and photoaged skin--a prospective clinical study on patient expectation and satisfaction. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

New Developments for Fractional Co2 Resurfacing for Skin Rejuvenation and Scar Reduction. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Early postoperative single treatment ablative fractional lasing of Mohs micrographic surgery facial scars: a split-scar, evaluator-blinded study. [2015]

6. France pubmed.ncbi.nlm.nih.gov

[CO₂ fractional resurfacing: side effects and immediate complications]. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

Fractional CO(2) laser resurfacing. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Dystrophic calcification and accentuated localized Argyria after fractionated carbon dioxide laser therapy of hypertrophic scars. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Scarring and persistent erythema after fractionated ablative CO2 laser resurfacing. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Ablative skin resurfacing with a novel microablative CO2 laser. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Fractionated Er:YAG laser versus fully ablative Er:YAG laser for scar revision: Results of a split scar, double blinded, prospective trial. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Comparison study of fractional carbon dioxide laser resurfacing using different fluences and densities for acne scars in Asians: a randomized split-face trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

In vivo wound healing and dermal matrix remodelling in response to fractional CO(2) laser intervention: clinicopathological correlation in non-facial skin. [2012]