Status:
RECRUITING
Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis
Lead Sponsor:
Science Valley Research Institute
Conditions:
Stasis Dermatitis
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study tests two types of lasers (ND YAG 1064 short and ultra-short pulses) to treat hyperchromic skin lesions secondary to venous hypertension (stasis dermatitis)
Detailed Description
Background: Stasis dermatitis with hyperpigmented skin lesions is a serious health problem for patients with chronic venous hypertension. Although no randomized studies have evaluated lasers for this ...
Eligibility Criteria
Inclusion
- Women or men aged 18 to 89 years with stasis dermatitis secondary to venous hypertension
- Agreement with the terms of the survey and signing of the informed consent form
- Availability to make the necessary appointments for treatment and follow-up
- Provide consent to avoid pregnancy during treatment
- Have primary venous hypertension already treated (treatment of varicose veins of the lower limbs) by any of the available techniques
Exclusion
- Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.
- Peripheral arterial disease.
- History of known allergy to the drugs used in this study
- Presence of other types of dermatitis in the lower extremities, such as allergic stasis eczema.
- Presence of comorbidities (such as diabetes mellitus, heart failure, respiratory failure, hypertension, hypothyroidism, or hyperthyroidism), pregnancy, breastfeeding, pulmonary hypertension, deep vein thrombosis (DVT), family history of DVT, known hypercoagulable states or thrombophilia, asthma, and migraine.
- Anyone who does not agree with any of the search terms.
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Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06980961
Start Date
May 20 2025
End Date
December 1 2026
Last Update
May 20 2025
Active Locations (1)
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1
Clinica Ramacciotti
Santo André, São Paulo, Brazil, 09090401