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Dose-response Relationship Study of S42909 on Leg Ulcer Healing

Primary Purpose

Venous Leg Ulcer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
S42909 100 mg
S42909 200 mg
S42909 400 mg
S42909 800 mg
S42909 1200 mg
Placebo Oral Tablet
Sponsored by
Ilkos Therapeutic Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%.

Sites / Locations

  • ILD Research Center
  • Center for Clinical Research Inc.
  • Center for Clinical Research Inc.
  • Limb Preservation Platform, Inc.
  • Foot and Ankle Clinic
  • Stanford Hospitals and Clinics
  • Center for Clinical Research Inc.
  • University of Miami Hospital Wound Center
  • St. Luke's Intermountain Research Center
  • Podiatry 1st
  • Advanced Foot & Ankle Center
  • The Snyder Institute for Vascular Health and Research
  • D&P Medical Group, LLC
  • Serena Group Research Foundation
  • Centro Dr Bottini de flebologia y estetica
  • Hospital Italiano de La Plata
  • DIM Clinica Privada
  • Sanatorio Mapaci
  • Medizinische Universitaet Innsbruck Universitaetsklinik für Gefässchirurgie
  • VENEX Zentrum fuer minimal invasive Venentherapie
  • Medizinische Universitaet Wien AKH- Dermatologie
  • Faculdade de Medicina de Botucatu
  • Hospital das Clinicas de Porto Alegre
  • Faculdade de Medicina do ABC Cepes
  • Centro Multidisciplinar de Estudos Clinicos CEMEC
  • Hospital Sao Paulo
  • Hospital Sao Vicente de Paulo
  • Alberta Health Services
  • Parkwood Institute
  • Toronto Regional Dermatology & Wound Healing Clinic
  • Ottawa Hospital Civic Campus
  • Centrepoint Medical Center
  • York Dermatology Center
  • Centre Hospitalier Universitaire de Sherbrooke
  • I. Dermatovenerologicka Klinika
  • MATMED s.r.o.
  • Nemocnice Jihlava Chirurgie A
  • Nemocnice Trebic Kozni oddeleni p.o.
  • Angiocor s.r.o.
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Peterfy Sandor Utcai Korhaz
  • Egyesitett Szent Istvan es Szent
  • Bajcsy-Zsilinsky Korhaz
  • Magyar Honvedseg Egeszsegugyi
  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
  • Bacs-Kiskun Megyei Korhaz
  • Josa Andras Oktatokorhaz
  • Pesi Tudomanyegyetem Klnikai Kozpont
  • Szegedi Tudomanyegyetem Borgyogyaszati es Allergologiai Klinica
  • Azienda Ospedaliera San Giuseppe Moscati Medicina interna
  • Ospedale San Bassiano - Azienda ULSS n. 7 Pedemontana - Ambulatorio di Vulnologia
  • Ospedale San Giacomo Apostolo Castelfranco Veneto - U.O. Angiologia
  • Policlinico Vittorio Emanuele - Presidio Ospedaliero Vittorio Emanuele
  • Azienda Ospedaliero Universitaria di Padova U.O. Angiologia - Medicina Vascolare
  • Istituto Neurologico Mediterraneo NEUROMED U.O.C. Chirurgia Vascolare ed Endovascolare
  • Ospedale Basso Ionio ASPCZ U.O.C. Chirurgia Generale, P.O. di Soverato
  • Ospedale Belcolle - U.O Angiologia
  • ClinicMed Daniluk
  • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
  • Medical Academy of Lublin
  • SP Szpital Kliniczny Nr1
  • Klinika Flebologii
  • ALIAN, s.r.o., Poliklinika ČK plus
  • BeneDerma
  • Derm-Therapy
  • M.M.-Angio spol. s r.o., Angiologicka ambulancia
  • ANGIOCARE, s.r.o.
  • ALIAN, s.r.o., Angiologická ambulancia
  • Dermatovenerologicke oddelenie SANARE, spol. s r.o.
  • Nemocnica arm. generala L. Svobodu Svidnik
  • MEDENA s.r.o., Angiologicka ambulancia
  • MEDIVASA, s.r.o.
  • Fundacion Hospital de Aviles
  • Hospital Vall d'Hebron
  • Consorci Sanitari de Terrassa - Hospital de Terrassa
  • Hospital Universitario de Getafe
  • Hospital de la Cruz Roja de Madrid
  • Hospital Clínico San Carlos
  • Complejo Asistencial Universitario
  • Hospital de Manises

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Arm Description

S42909 dose 100 mg p.o., 50 mg bid

S42909 dose 200 mg p.o., 100 mg bid

S42909 dose 400 mg p.o., 200 mg bid

S42909 dose 800 mg p.o., 400 mg bid

S42909 dose 1200 mg p.o., 600 mg bid

Placebo p.o. bid

Outcomes

Primary Outcome Measures

Relative Reduction of Reference Ulcer Area After 4 Weeks of Treatment on Top of Standard of Care Compared With Baseline Reference Ulcer Area (W000) Assessed During Study Visits
Change of reference Ulcer area measurement in cm^2 from Baseline to Week 4.

Secondary Outcome Measures

Adverse Events
Occurring during the double-blind period of the study
Assessment of Laboratory Parameters
Biochemistry, Haematology and Fasting Lipids

Full Information

First Posted
March 1, 2017
Last Updated
September 14, 2020
Sponsor
Ilkos Therapeutic Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03077165
Brief Title
Dose-response Relationship Study of S42909 on Leg Ulcer Healing
Official Title
A 10-week Randomized, Double-blind, Placebo-controlled, Prospective, International, Multicentre, Phase IIa Study of S42909 on Leg Ulcer Healing.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ilkos Therapeutic Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.
Detailed Description
S42909 is an inhibitor of β-Nicotinamide Adenine Dinucleotide Phosphate (NADPH) oxidase which also inhibits vascular leukocyte adhesion to endothelial cells, Matrix Metalloproteinase-2 (MMP-2) and Plasminogen Activator Inhibitor-1 (PAI-1) activity. It is proposed for development in the treatment of venous and mixed leg ulcers. This proof of concept study is a randomized, double-blind, placebo-controlled, multicenter, Phase IIa trial to evaluate the dose response of S42909 for the treatment of venous leg ulcers. Patients suffering from chronic venous disease and having at least one active venous leg ulcer will be selected at the selection visit (ASSE). One Reference Ulcer (RU) defined as the largest ulcer in size that is fitting the area selection criteria will be established. At ASSE, a first picture will be taken before cleansing and debridement and a second picture will be taken after cleansing and debridement. The investigator will check that the selection RU area is compliant with the selection criteria. Patients will start the selection period and will be switched from their current pharmacological and/or local treatment (if any) for venous leg ulcer to local wound care with sterile saline solution or sterile water, "non-active" dressings and standardized compression (same strength and type of compression). They will be administrated the placebo selection treatment for a period of fourteen days. Three (or four) working days before the inclusion visit, the participants will come to the site for a RU picture in order to get the RU area central measurement for inclusion visit (W000). At W000, the investigator will check that the inclusion RU area is compliant with the inclusion criteria. The investigator will also check that the participant is compliant with the selection treatment and stockings wearing. All participants found to be eligible for inclusion will be randomized to one of the following six groups - S42909: 100, 200, 400, 800 or 1200 mg per day- or placebo. The participants will enter a 6 weeks ambulatory Investigational Medicinal Product (IMP) treatment period on top of standard of care (standardized compression and local wound care with sterile saline solution or sterile water and "non-active" dressing) followed by a 2 weeks follow-up period of standard of care only. During this period the participants will return to the investigator's site for intermediate visits after one week (W001), two weeks (W002), three weeks (W003), four weeks (W004), six weeks (W006) and eight weeks (W008). Participants will continue receiving standardized compression therapy and local wound care (sterile saline solution or sterile water and "non-active" dressing) until the end of the study (W008).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
S42909 dose 100 mg p.o., 50 mg bid
Arm Title
Group B
Arm Type
Experimental
Arm Description
S42909 dose 200 mg p.o., 100 mg bid
Arm Title
Group C
Arm Type
Experimental
Arm Description
S42909 dose 400 mg p.o., 200 mg bid
Arm Title
Group D
Arm Type
Experimental
Arm Description
S42909 dose 800 mg p.o., 400 mg bid
Arm Title
Group E
Arm Type
Experimental
Arm Description
S42909 dose 1200 mg p.o., 600 mg bid
Arm Title
Group F
Arm Type
Placebo Comparator
Arm Description
Placebo p.o. bid
Intervention Type
Drug
Intervention Name(s)
S42909 100 mg
Intervention Description
50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Intervention Type
Drug
Intervention Name(s)
S42909 200 mg
Intervention Description
50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Intervention Type
Drug
Intervention Name(s)
S42909 400 mg
Intervention Description
200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Intervention Type
Drug
Intervention Name(s)
S42909 800 mg
Intervention Description
200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.
Intervention Type
Drug
Intervention Name(s)
S42909 1200 mg
Intervention Description
200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.
Primary Outcome Measure Information:
Title
Relative Reduction of Reference Ulcer Area After 4 Weeks of Treatment on Top of Standard of Care Compared With Baseline Reference Ulcer Area (W000) Assessed During Study Visits
Description
Change of reference Ulcer area measurement in cm^2 from Baseline to Week 4.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Occurring during the double-blind period of the study
Time Frame
Up to 8 weeks
Title
Assessment of Laboratory Parameters
Description
Biochemistry, Haematology and Fasting Lipids
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eberhard Rabe, Professor
Organizational Affiliation
Department of Dermatology University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
ILD Research Center
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Center for Clinical Research Inc.
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Center for Clinical Research Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Limb Preservation Platform, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Foot and Ankle Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Stanford Hospitals and Clinics
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Center for Clinical Research Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Miami Hospital Wound Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
St. Luke's Intermountain Research Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Podiatry 1st
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Advanced Foot & Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
The Snyder Institute for Vascular Health and Research
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States
Facility Name
D&P Medical Group, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Serena Group Research Foundation
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Centro Dr Bottini de flebologia y estetica
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1115AAE
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
La Plata
ZIP/Postal Code
B1900AXI
Country
Argentina
Facility Name
DIM Clinica Privada
City
Ramos Mejía
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Sanatorio Mapaci
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Medizinische Universitaet Innsbruck Universitaetsklinik für Gefässchirurgie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
VENEX Zentrum fuer minimal invasive Venentherapie
City
Wien
ZIP/Postal Code
1080
Country
Austria
Facility Name
Medizinische Universitaet Wien AKH- Dermatologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Faculdade de Medicina de Botucatu
City
Botucatu
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Faculdade de Medicina do ABC Cepes
City
Santo André
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Centro Multidisciplinar de Estudos Clinicos CEMEC
City
São Bernardo Do Campo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Hospital Sao Paulo
City
São Paulo
ZIP/Postal Code
04037-002
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Teixeira Soares
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R 0X7
Country
Canada
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Facility Name
Toronto Regional Dermatology & Wound Healing Clinic
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 1A6
Country
Canada
Facility Name
Ottawa Hospital Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Centrepoint Medical Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
York Dermatology Center
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
I. Dermatovenerologicka Klinika
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
MATMED s.r.o.
City
Hodonín
ZIP/Postal Code
69501
Country
Czechia
Facility Name
Nemocnice Jihlava Chirurgie A
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Nemocnice Trebic Kozni oddeleni p.o.
City
Třebíč
ZIP/Postal Code
674 01
Country
Czechia
Facility Name
Angiocor s.r.o.
City
Zlín
ZIP/Postal Code
76001
Country
Czechia
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Peterfy Sandor Utcai Korhaz
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Egyesitett Szent Istvan es Szent
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Bajcsy-Zsilinsky Korhaz
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Josa Andras Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pesi Tudomanyegyetem Klnikai Kozpont
City
Pécs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Borgyogyaszati es Allergologiai Klinica
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Azienda Ospedaliera San Giuseppe Moscati Medicina interna
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Ospedale San Bassiano - Azienda ULSS n. 7 Pedemontana - Ambulatorio di Vulnologia
City
Bassano Del Grappa
ZIP/Postal Code
36061
Country
Italy
Facility Name
Ospedale San Giacomo Apostolo Castelfranco Veneto - U.O. Angiologia
City
Castelfranco Veneto
ZIP/Postal Code
31033
Country
Italy
Facility Name
Policlinico Vittorio Emanuele - Presidio Ospedaliero Vittorio Emanuele
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Padova U.O. Angiologia - Medicina Vascolare
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Istituto Neurologico Mediterraneo NEUROMED U.O.C. Chirurgia Vascolare ed Endovascolare
City
Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
Ospedale Basso Ionio ASPCZ U.O.C. Chirurgia Generale, P.O. di Soverato
City
Soverato
ZIP/Postal Code
88068
Country
Italy
Facility Name
Ospedale Belcolle - U.O Angiologia
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
ClinicMed Daniluk
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Medical Academy of Lublin
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
SP Szpital Kliniczny Nr1
City
Poznań
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Klinika Flebologii
City
Warsaw
ZIP/Postal Code
02-034
Country
Poland
Facility Name
ALIAN, s.r.o., Poliklinika ČK plus
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
BeneDerma
City
Bratislava
ZIP/Postal Code
84102
Country
Slovakia
Facility Name
Derm-Therapy
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
M.M.-Angio spol. s r.o., Angiologicka ambulancia
City
Dunajská Streda
ZIP/Postal Code
929 01
Country
Slovakia
Facility Name
ANGIOCARE, s.r.o.
City
Košice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
ALIAN, s.r.o., Angiologická ambulancia
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Dermatovenerologicke oddelenie SANARE, spol. s r.o.
City
Svidník
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Nemocnica arm. generala L. Svobodu Svidnik
City
Svidník
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
MEDENA s.r.o., Angiologicka ambulancia
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia
Facility Name
MEDIVASA, s.r.o.
City
Žilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Fundacion Hospital de Aviles
City
Avilés
ZIP/Postal Code
33402
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Consorci Sanitari de Terrassa - Hospital de Terrassa
City
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Getafe
ZIP/Postal Code
280902
Country
Spain
Facility Name
Hospital de la Cruz Roja de Madrid
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Complejo Asistencial Universitario
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital de Manises
City
Valencia
ZIP/Postal Code
46940
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Dose-response Relationship Study of S42909 on Leg Ulcer Healing

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