Dose-response Relationship Study of S42909 on Leg Ulcer Healing

Completed · Phase 2 · Has a placebo group

Conditions studied: Venous Leg Ulcer

In brief

Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.

Key facts

Study ID

NCT03077165

Run by

Ilkos Therapeutic Inc.

People needed

121

Starts

2017-09-12

Expected to finish

2020-01-22

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Caucasian (defined for this study as having 2 Caucasian parents), men or women
• Age ≥ 18 years old
• 18.5 kg/m2 ≤ BMI ≤ 45.0 kg/m2 (= Weight (kg) / height² (m²))
• Patients with chronic venous disease documented by imaging to detect a venous disorder in one or both the sub- and extra-fascial venous systems. The examination performed within 6 months before selection can be used.
• Patients with at least one active venous leg ulcer localised in the gaiter area (CEAP C6) diagnosed or reoccurred for more than 6 weeks and less than 2 years at selection and 3 cm away from other ulcers. Patients with bilateral ulcerations or multiple ulcerations on one or both legs are eligible for selection.
• Size of Reference Ulcer (defined as the largest ulcer in size that is fitting the area selection criteria) should be ≥ 5 cm2 and ≤ 100 cm2 at the selection visit and ≥ 4.5 cm2 and ≤ 100 cm2 at the inclusion visit (measured by transparent sheet and confirmed with the digital 3D imaging device).
• Ankle Brachial Pressure Index (ABPI) ≥ 0.8 and ≤ 1.3 measured by Doppler ultrasound.

You may not qualify if…

• Unlikely or unwilling to be compliant to standardized compression recommendation, study medication and visits, previous records of poor compliance to compression stockings.
• Inadequately controlled type 1 and type 2 diabetes with an HbA1c > 8%.

Where it is running

• Center for Clinical Research Inc. — Carmichael, California, United States
• Center for Clinical Research Inc. — Castro Valley, California, United States
• Limb Preservation Platform, Inc. — Fresno, California, United States
• Foot and Ankle Clinic — Los Angeles, California, United States
• Stanford Hospitals and Clinics — Redwood City, California, United States
• Center for Clinical Research Inc. — San Francisco, California, United States
• University of Miami Hospital Wound Center — Miami, Florida, United States
• St. Luke's Intermountain Research Center — Boise, Idaho, United States
• Podiatry 1st — Belleville, Illinois, United States
• Advanced Foot & Ankle Center — Las Vegas, Nevada, United States
• The Snyder Institute for Vascular Health and Research — Kittanning, Pennsylvania, United States
• D&P Medical Group, LLC — Pittsburgh, Pennsylvania, United States
• Serena Group Research Foundation — Pittsburgh, Pennsylvania, United States
• Centro Dr Bottini de flebologia y estetica — Ciudad Autonoma de Buenos Aire, Argentina
• Hospital Italiano de La Plata — La Plata, Argentina
• DIM Clinica Privada — Ramos Mejía, Argentina
• Sanatorio Mapaci — Rosario, Argentina
• Medizinische Universitaet Innsbruck Universitaetsklinik für Gefässchirurgie — Innsbruck, Austria
• VENEX Zentrum fuer minimal invasive Venentherapie — Vienna, Austria
• Medizinische Universitaet Wien AKH- Dermatologie — Vienna, Austria
• Faculdade de Medicina de Botucatu — Botucatu, Brazil
• Hospital das Clinicas de Porto Alegre — Porto Alegre, Brazil
• Faculdade de Medicina do ABC Cepes — Santo André, Brazil
• Centro Multidisciplinar de Estudos Clinicos CEMEC — São Bernardo do Campo, Brazil
• ILD Research Center — Carlsbad, California, United States

Full record on ClinicalTrials.gov

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