Published in the International Wound Journal
We are proud to announce the publication of a prospective randomised controlled trial evaluating high-intensity Er:YAG laser therapy with RecoSMA® technology versus conventional sharp debridement for the treatment of chronic lower-extremity ulcers.
The study, published in the International Wound Journal, included 144 patients with diabetic foot ulcers, venous leg ulcers, and arterial ulcers.
Study Overview
The trial compared two approaches:
The primary endpoints included:
Key Clinical Findings
1️⃣ Significantly Higher Wound Closure Rate
After 30 days:
This represents more than a twofold increase in full wound closure.
2️⃣ Faster Wound Bed Preparation
Laser-treated wounds demonstrated:
3️⃣ Greater Reduction in Wound Area
At day 30:
Among diabetic foot ulcers, the average PWAR reached 84%.
4️⃣ Enhanced Bacterial Clearance
By day 15:
This supports the laser’s ability to disrupt biofilms and reduce microbial burden.
5️⃣ Regenerative Cytological Shift
Cytology analysis revealed:
At day 30, regenerative cytograms were substantially more prevalent in the treatment group.
6️⃣ High Tolerability
Laser debridement was reported as painless in:
No adverse events were reported.
Why This Matters
Chronic wounds are frequently stalled by:
This study demonstrates that high-intensity Er:YAG laser therapy combined with RecoSMA® technology offers:
Without adding secondary thermal damage to fragile tissue.
A Step Forward in Regenerative Wound Management
The findings suggest that Er:YAG laser therapy in ablation + RecoSMA® mode is a clinically effective and safe alternative to conventional sharp debridement for chronic lower limb ulcers. This publication reinforces the growing body of evidence supporting regenerative laser-based wound management strategies.
We are proud to announce the publication of a prospective randomised controlled trial evaluating high-intensity Er:YAG laser therapy with RecoSMA® technology versus conventional sharp debridement for the treatment of chronic lower-extremity ulcers.
The study, published in the International Wound Journal, included 144 patients with diabetic foot ulcers, venous leg ulcers, and arterial ulcers.
Study Overview
The trial compared two approaches:
- Treatment group (n=71): High-intensity Er:YAG laser ablation followed by RecoSMA® regenerative mode
- Control group (n=73): Conventional sharp surgical debridement
The primary endpoints included:
- Time to clean the wound bed
- Time to granulation
- Marginal and complete epithelialisation
- Percentage wound area reduction
- Bacterial clearance
- Cytological wound progression
Key Clinical Findings
1️⃣ Significantly Higher Wound Closure Rate
After 30 days:
- 56.3% of wounds in the laser group achieved complete epithelialisation
- Compared to 26% in the control group
- (p < 0.001)
This represents more than a twofold increase in full wound closure.
2️⃣ Faster Wound Bed Preparation
Laser-treated wounds demonstrated:
- Earlier detritus clearance
- Faster granulation tissue formation
- Earlier marginal epithelialisation
3️⃣ Greater Reduction in Wound Area
At day 30:
- 79% average percentage wound area reduction (PWAR) in the laser group
- Compared to 58% in the control group
Among diabetic foot ulcers, the average PWAR reached 84%.
4️⃣ Enhanced Bacterial Clearance
By day 15:
- 67.6% of laser-treated wounds showed no bacterial growth
- Compared to 46.5% in the control group
- (p < 0.001)
This supports the laser’s ability to disrupt biofilms and reduce microbial burden.
5️⃣ Regenerative Cytological Shift
Cytology analysis revealed:
- Higher proportion of regenerative cells in the laser group
- Lower persistence of inflammatory cell dominance
At day 30, regenerative cytograms were substantially more prevalent in the treatment group.
6️⃣ High Tolerability
Laser debridement was reported as painless in:
- 69% of patients in ablation mode
- 100% of patients in RecoSMA® mode
No adverse events were reported.
Why This Matters
Chronic wounds are frequently stalled by:
- Biofilm persistence
- Non-viable tissue
- Prolonged inflammatory dominance
- Impaired microcirculation
This study demonstrates that high-intensity Er:YAG laser therapy combined with RecoSMA® technology offers:
- Precise removal of necrotic tissue
- Biofilm disruption
- Stimulation of neovascularisation
- ECM remodeling
- Anti-fibrotic biological activation
Without adding secondary thermal damage to fragile tissue.
A Step Forward in Regenerative Wound Management
The findings suggest that Er:YAG laser therapy in ablation + RecoSMA® mode is a clinically effective and safe alternative to conventional sharp debridement for chronic lower limb ulcers. This publication reinforces the growing body of evidence supporting regenerative laser-based wound management strategies.
