Scientific Publications

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

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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