Randomized Clinical Trial on Er:YAG + RecoSMA® for Neuroischemic Diabetic Foot Ulcers Launched at Complutense University of Madrid

The study, titled:

“Effect of Erbium Laser on the Evolution of Neuroischemic Ulcers in Diabetic Feet,”

is being conducted at the Diabetic Foot Unit of the University Podiatry Clinic, Faculty of Medicine, Complutense University of Madrid.

Principal Investigator:

Prof. Dr. José Luis Lázaro Martínez

Co-Investigators:

Prof. Dr. Aroa Tardáguila García
Ms. Teeana Alexandra Luna Sánchez 28. MADRID RCT

Clinical Background

Neuroischemic diabetic foot ulcers represent one of the most complex and difficult-to-treat complications of diabetes mellitus. These lesions combine:

• Peripheral neuropathy
• Peripheral arterial disease
• Reduced tissue perfusion
• Chronic inflammation

Despite standardised treatment protocols—including debridement, dressings, offloading, and metabolic control—a significant proportion of ulcers remain hard-to-heal, increasing the risk of infection, recurrence, and amputation 28. MADRID RCT

Given the high lifetime incidence of diabetic foot ulcers and recurrence rates approaching 40% within one year, there is a clear need for adjunctive regenerative therapies.

Study Design

This investigation is a prospective, randomised, quasi-experimental study with a 1:1 allocation ratio:

• Intervention group: Er:YAG laser with RecoSMA® technology in addition to conventional care
• Control group: Conventional treatment alone

Participants will be followed for six weeks with structured weekly assessments.


The primary objective is to evaluate whether Er:YAG laser with RecoSMA® technology enhances tissue regeneration and accelerates healing in neuroischemic ulcers compared to standard therapy.

Secondary objectives include:

• Analysis of granulation tissue progression
• Evaluation of epithelialization rate
• Assessment of microcirculatory changes

Objective Perfusion Assessment

A distinctive feature of this trial is the integration of hyperspectral imaging for quantitative perfusion analysis.

The following parameters will be measured:

• Tissue oxygen saturation (StO₂%)
• Total haemoglobin (THb)
• Perfusion index
• Oxygenation gradient (ΔStO₂)

This approach enables objective evaluation of microvascular and oxygenation changes during treatment.

Biological Rationale

The protocol outlines a dual mechanism of action:

1. Er:YAG Laser Ablation
2. Precise removal of devitalized tissue with minimal thermal impact.
3. RecoSMA® Spatial Modulation
4. Division of the laser beam into microbeams generating controlled acoustic effects in superficial tissue layers.
5. These effects stimulate:

• Microcirculation
• Fibroblast activation
• Collagen synthesis
• Extracellular matrix remodeling
• Neovascularization

The study hypothesis states that Er:YAG + RecoSMA® promotes tissue regeneration, enhances granulation tissue formation, accelerates epithelialization, and reduces healing time compared to conventional treatment 28. MADRID RCT

Sample Size and Statistical Framework

The planned sample size is:

• 36 patients per group (72 total)

The study is powered to detect a clinically meaningful ≥20% difference in ulcer area reduction between groups, with statistical analysis performed using IBM SPSS software

Advancing Evidence in Regenerative Wound Care

This randomised clinical investigation represents an important step toward generating high-level evidence for:

• Laser-assisted regenerative wound management
• Objective perfusion-based outcome measurement
• Protocol-driven application of Er:YAG + RecoSMA® technology

LINLINE Medical Systems SIA is proud to support this academic collaboration and looks forward to the publication of the clinical results upon completion of the study.