Scientific Publications

Spatially Modulated Er:YAG Laser as a Treatment for Diabetic Foot Ulcers

2023-11-15 19:52
Diabetic foot ulcers (DFUs) remain one of the most severe and costly complications of diabetes, often leading to prolonged morbidity, infection, hospitalisation, and even amputation. In a 2023 study published in the Journal of Wound Care, Chilgar and Andurkar evaluated the effectiveness of spatially modulated Er:YAG laser therapy in the treatment of hard-to-heal diabetic ulcers .

This single-arm clinical study investigated whether combining laser debridement with deep tissue biostimulation could achieve complete wound closure without surgical intervention.

Study Overview

  • Design: Prospective single-arm clinical study
  • Setting: Plastic Surgery Department, Elrevo Clinic, India
  • Study period: November 2017 – April 2023
  • Sample size: 59 patients with diabetic ulcers
  • Primary endpoint: Complete wound closure
  • Secondary endpoints: Time to closure, number of laser sessions

Patients were included if they had hard-to-heal diabetic ulcers and were willing to continue treatment until full healing occurred. Ulcers were classified according to Wagner grading.

Patient Characteristics

  • Mean wound surface area at baseline: 25.7 cm² (median 12 cm²)
  • Average ulcer duration: 34 weeks
  • Most common location: Right plantar forefoot (27.1%)
  • Comorbidities:
  • 39% had hypertension
  • 81% had diabetes for 1–10 years
  • Mean blood glucose level: 236 mg/dl

Most ulcers (69.5%) had a surface area ≤25 cm² .

Treatment Protocol: Two-Step Er:YAG + RecoSMA Approach

All patients underwent a standardized two-step protocol weekly until healing.

🔹 Step 1 – High-Power Er:YAG Laser Ablation (Debridement)

  • Wavelength: 2940 nm
  • Frequency: 3 Hz
  • Energy density: 15.9 J/cm²
  • 4 mm laser tip
  • Non-contact technique
  • Endpoint: capillary bleeding

This stage removed necrotic tissue and biofilm via rapid tissue vaporisation (>300°C), without causing thermal damage to surrounding viable tissue. The procedure was performed in an outpatient setting without the need for anaesthesia.

🔹 Step 2 – RecoSMA Biostimulation

  • Frequency: 3 Hz
  • Energy density: 2.30 J/cm²
  • Contact application
  • Treatment of wound bed, edges, and 3 cm periphery

RecoSMA technology divides laser energy into multiple microbeams, producing mechanical microdestruction and acoustic resonance in deeper tissues. This re-triggers the inflammatory phase of healing, stimulates neovascularisation, enhances collagen synthesis, and promotes extracellular matrix remodelling.

Standard Wound Care

In addition to laser therapy, patients received:

  • Alternate-day dressing changes
  • Topical antiseptics
  • Oral antibiotics when indicated (62.7%)
  • Offloading for plantar ulcers
  • Clinical photographic documentation during each session

Results

1️⃣ Complete Healing Achieved in All Patients

All 59 diabetic ulcers healed completely by the end of treatment.

  • Average number of sessions: 4.41 (range 1–11)
  • Majority (69.5%) required ≤5 sessions
  • Wound size reduced progressively with each treatment

This represents a 100% closure rate within the treated cohort .

2️⃣ Factors Influencing Number of Sessions

Statistically significant factors associated with needing more sessions:

  • Initial wound surface area >25 cm² (p=0.001)
  • Presence of oedema (p=0.007)
  • Hypertension (p=0.027)

Smaller wounds achieved closure more rapidly.

3️⃣ Long-Term Follow-Up

  • Follow-up range: 4–70 months
  • Average follow-up: ~23 months
  • Recurrence rate: 0% at the same site

This suggests durable healing and sustained tissue regeneration.

Mechanism of Action

The study highlights a synergistic dual mechanism:

  1. Laser Ablation

  • Precise removal of necrotic tissue and biofilm
  • Reduced microbial burden
  • Minimal collateral damage

  1. RecoSMA Biostimulation

  • Mechanical cavitation effect in deeper tissue
  • Reactivation of inflammatory cascade
  • Stimulation of fibroblast proliferation
  • Enhanced collagen and ECM formation

The authors describe this as a “holistic solution” combining wound cleansing and activation of endogenous healing pathways .

Clinical Implications

This study suggests that spatially modulated Er:YAG laser therapy:

  • Can achieve complete closure of diabetic ulcers up to 25 cm² without surgery
  • May reduce need for operating theatre-based sharp debridement
  • Provides outpatient, minimally invasive treatment
  • Demonstrates long-term durability of healing

Given the high amputation risk associated with diabetic ulcers, these findings are clinically significant.

Limitations

The authors acknowledge:

  • Single-arm design (no control group)
  • Moderate sample size
  • Potential variability in wound measurement
  • No histological confirmation of regenerated tissue
  • Limited generalisability

Further multicentre controlled studies are recommended.

Conclusion

In this prospective clinical study, spatially modulated Er:YAG laser therapy achieved complete wound closure in all 59 hard-to-heal diabetic ulcers with an average of 4.4 treatment sessions. The two-step protocol combining laser ablation and RecoSMA biostimulation appears to offer a promising, non-surgical approach to diabetic foot ulcer management.
Source:

Chilgar RM, Andurkar SP. Spatially modulated erbium YAG laser as a treatment for diabetic ulcer. Journal of Wound Care. 2023;32(Silk Road Supplement):S21–S29 .

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