Chronic lower extremity ulcers — including diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and arterial ulcers — remain one of the most challenging conditions in wound care. Biofilm formation, prolonged inflammation, and delayed regeneration significantly impair healing outcomes. A prospective randomised controlled trial (RCT) published in International Wound Journal (2025) evaluated whether high-intensity Er:YAG laser therapy combined with RecoSMA technology offers clinical advantages over traditional sharp debridement .
Study Design
The trial was conducted between 2018 and 2021 in Russia and included 144 patients with chronic lower limb ulcers:
Both groups were comparable at baseline in:
Patients were observed for 30 days or until wound closure, whichever occurred first.
Treatment Protocol
🔹 Laser Group
Two-step approach:
Step 1 – High-intensity Er:YAG ablation
Step 2 – RecoSMA biostimulation
Treatment time averaged 15 minutes per session.
🔹 Control Group
Primary Outcomes
1️⃣ Complete Epithelialisation (Day 30)
2️⃣ Faster Wound Bed Preparation
Laser therapy achieved:
These findings indicate accelerated progression through key healing phases .
3️⃣ Greater Wound Size Reduction
After 30 days:
In diabetic ulcers specifically:
Unhealed wounds still demonstrated greater shrinkage in the laser group (69% vs 53%) .
4️⃣ Superior Bacterial Clearance
At Day 15:
At Day 30 (among unhealed wounds):
Laser therapy demonstrated stronger biofilm disruption capacity .
5️⃣ Cytological Evidence of Regeneration
At Day 30 (unhealed wounds):
This suggests a biological shift toward active tissue repair with laser treatment .
6️⃣ Patient Tolerability
No adverse events were reported in either group .
Clinical Interpretation
This RCT demonstrates that Er:YAG laser therapy with RecoSMA:
Importantly, these benefits were observed across diabetic, venous, and arterial ulcers — conditions often characterised by long-standing inflammation and biofilm persistence.
Study Limitations
The authors note:
Despite these limitations, this remains one of the largest RCTs comparing Er:YAG laser therapy to sharp debridement in chronic lower limb ulcers.
Conclusion
Within 30 days, Er:YAG laser therapy combined with RecoSMA technology demonstrated significantly improved healing outcomes compared to conventional sharp debridement. The treatment not only accelerated wound cleansing and regeneration but also doubled the rate of complete epithelialisation while offering superior patient tolerability.
These findings support the integration of spatially modulated Er:YAG laser therapy as a potential advanced modality in chronic wound management.
Source:
Zaitsev AE, Asanov ON. Erbium:Yttrium Aluminium Garnet (Er:YAG) Laser Therapy Versus Sharp Debridement in the Management of Chronic Ulcers of the Lower Extremity: A Randomised Control Trial. International Wound Journal. 2025;22:e70688 .
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Study Design
The trial was conducted between 2018 and 2021 in Russia and included 144 patients with chronic lower limb ulcers:
- Treatment group (n=71): Er:YAG laser ablation + RecoSMA biostimulation
- Control group (n=73): Conventional sharp debridement
Both groups were comparable at baseline in:
- Age (mean ~55–56 years)
- Ulcer duration (median ~16 months)
- Ulcer size (mean ~14 cm²)
- Aetiology (DFU, venous, arterial)
- Bacterial contamination levels
Patients were observed for 30 days or until wound closure, whichever occurred first.
Treatment Protocol
🔹 Laser Group
Two-step approach:
Step 1 – High-intensity Er:YAG ablation
- 2940 nm wavelength
- 10–15 J/cm²
- Removal of necrotic tissue and biofilm
- Endpoint: capillary bleeding
Step 2 – RecoSMA biostimulation
- 2–4 J/cm²
- Microbeam energy distribution
- Acoustic wave penetration up to 6 mm
- Stimulation of microcirculation, tissue metabolism, and regeneration
Treatment time averaged 15 minutes per session.
🔹 Control Group
- Surgical sharp debridement in the operating theatre
- Local anaesthetic irrigation
- Standard antimicrobial dressings
- Offloading when indicated
Primary Outcomes
1️⃣ Complete Epithelialisation (Day 30)
- 56% in laser group
- 26% in control group
- p < 0.001
2️⃣ Faster Wound Bed Preparation
Laser therapy achieved:
- Faster detritus clearance: 3.9 days vs 5.4 days (p < 0.001)
- Earlier granulation: 6.2 vs 7.7 days (p < 0.001)
- Earlier marginal epithelialisation: 8.5 vs 10.4 days (p < 0.001)
These findings indicate accelerated progression through key healing phases .
3️⃣ Greater Wound Size Reduction
After 30 days:
- 79% average reduction (laser group)
- 58% reduction (control group)
In diabetic ulcers specifically:
- Average reduction reached 84% in the laser group.
Unhealed wounds still demonstrated greater shrinkage in the laser group (69% vs 53%) .
4️⃣ Superior Bacterial Clearance
At Day 15:
- 67.6% of laser-treated wounds showed no bacterial growth
- 46.5% in control group
- p < 0.001
At Day 30 (among unhealed wounds):
- 74% of laser wounds had no detectable microflora
- 63% in control group
Laser therapy demonstrated stronger biofilm disruption capacity .
5️⃣ Cytological Evidence of Regeneration
At Day 30 (unhealed wounds):
- Regenerative cells: 38.7% (laser) vs 14.8% (control)
- Inflammatory cells: lower in laser group (9.7% vs 29.6%)
This suggests a biological shift toward active tissue repair with laser treatment .
6️⃣ Patient Tolerability
- 69% reported painless laser ablation
- 100% reported painless RecoSMA phase
- Only 34% reported painless sharp debridement
No adverse events were reported in either group .
Clinical Interpretation
This RCT demonstrates that Er:YAG laser therapy with RecoSMA:
- Accelerates wound bed preparation
- Enhances granulation and epithelialisation
- Reduces bacterial burden
- Achieves higher early wound closure rates
- Provides superior patient comfort
Importantly, these benefits were observed across diabetic, venous, and arterial ulcers — conditions often characterised by long-standing inflammation and biofilm persistence.
Study Limitations
The authors note:
- No long-term follow-up beyond 30 days
- Lack of blinding
- No subgroup analysis
- Neuropathy status not recorded
- Quality-of-life measures not fully assessed
Despite these limitations, this remains one of the largest RCTs comparing Er:YAG laser therapy to sharp debridement in chronic lower limb ulcers.
Conclusion
Within 30 days, Er:YAG laser therapy combined with RecoSMA technology demonstrated significantly improved healing outcomes compared to conventional sharp debridement. The treatment not only accelerated wound cleansing and regeneration but also doubled the rate of complete epithelialisation while offering superior patient tolerability.
These findings support the integration of spatially modulated Er:YAG laser therapy as a potential advanced modality in chronic wound management.
Source:
Zaitsev AE, Asanov ON. Erbium:Yttrium Aluminium Garnet (Er:YAG) Laser Therapy Versus Sharp Debridement in the Management of Chronic Ulcers of the Lower Extremity: A Randomised Control Trial. International Wound Journal. 2025;22:e70688 .
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