A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).

NCT04181320 | Terminated Results DMC

• 1 other identifier: Granulox01 (PD-568268)
• Study Type: interventional
• Target: 128
• Locations: 7 countries
• Sites: 27

Brief Summary

The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation. 254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox added as an adjunct therapy in predominantly venous leg ulcer subjects. Standard of care wound management will be completed, including wound cleansing, debridement if necessary and application of a suitable dressing and compression system until complete wound closure. The study will be divided into two phases. Firstly, a two week run-in period to ensure compliance to compression therapy followed by a 20 weeks treatment period starting with randomization and allocation of treatment.

Conditions

Venous Leg Ulcer

Keywords

Granulox; venous ulcers; wound healing; wound reduction

Outcome Measures

Primary Outcomes (1)

• Confirmed Complete Wound Closure

  Confirmed Complete wound Closure is defined as an blinded assessment and observation of 100% re-epithelialization, confirmed by a second visit 15 days later (+/- 3 days).

  Up to 20 weeks post therapy initiation

Study Arms (2)

Venous Leg Ulcer Standard of Care

NO INTERVENTION

Subjects will recieve standard of care treatment.

Venous Leg Ulcer Standard of Care with Granulox

EXPERIMENTAL

Subjects will recieve standard of care treatment with Granulox added as an adjunct therapy.

Device: Venous Leg Ulcer Standard of Care with Granulox

Interventions

Venous Leg Ulcer Standard of Care with Granulox DEVICE

Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.

Also known as: Granulox

Venous Leg Ulcer Standard of Care with Granulox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed consent to participate.
• No planned hospitalization in the forthcoming 20 weeks.
• Male or female (women of childbearing age must have an acceptable method of birth control).
• Age \>18 years.
• Recent (less than 12 months) doppler or duplex colour ultrasonography compatible with chronic venous insufficiency.
• ABPI (less than 3 months) ≥0.7 for both legs. If ABPI \>1.4, then big toe pressure \>60mmHg is required or an alternative measurement verifying normal distal arterial flow.
• At least one or more supra- or peri-malleolar leg ulcers and no foot ulcer or another chronic wound.
• In case of two or more ulcers, select ulcer with the highest PUSH score at randomization and treat the non-selected ulcer in the same way as ulcers in the control group (standard of care).
• In case of two or more ulcers on the same limb, ensure that the distance between each ulcer is 3 cm as measured from the margins of each ulcer that are closest to one another.
• Wound duration ≥ 8 weeks and ≤60 months.
• At randomization, the ulcer area should be 3 cm2 - 70 cm² and should not have decreased by more than 30% during the 2-week run-in period.
• Less than 50% of the wound area should be covered with fibrinous tissue at randomization and after debridement.
• Patients considered as compliant/adherent to the compression device during the run-in period (i.e. no more than 2 days without compression over the 2-week run-in period).
• No clinically significant comorbidities requiring the use of systemic steroids or any cytotoxic or immunosuppressive agents.

You may not qualify if:

• Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at randomization.
• Circumferential wounds.
• Wound covered fully or partially by necrotic tissue (black tissue).
• Patients who will have problems following the protocol, especially compression therapy.
• Patients included in another on-going clinical investigation, or patients who have participated in a clinical investigation during the past 30 days.
• Wounds treated with dressings containing an active component (e.g. silver, nanooligosaccharide factor (NOSF), charcoal, chlorhexidine, iodine or ibuprofen) 14 days prior to study enrollment.
• Patient with a systemic infection not controlled by suitable antibiotic treatment.
• Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids (\>10 mg Predinsolone or equivalent) if any.
• Known allergy/hypersensitivity to the ingredients of the dressings and/or Granulox®.
• Malignant wounds.
• Endovenous surgery planned or performed within the past 30 days.
• Primary lymphoedema caused by congenital/developmental defect, i.e. Milroy's disease (congenital lymphedema), Meige's disease (lymphedema praecox), or Late-onset lymphedema (lymphedema tarda).

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (27)

Klinicki odjel za vaskularnu kirurgiju

Split, 21000, Croatia

Location

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Zavod za vaskularnu kirurgiju

Zagreb, 10000, Croatia

Location

Salvatella s.r.o.

Třinec, Dolni Lomna, 739 61, Czechia

Location

CHIR-Chirurgické oddeleni

Jihlava, 58633, Czechia

Location

U Nemocnice v Praze

Prague, 12808, Czechia

Location

Hopital Michallon

Grenoble, La Tronche, 38700, France

Location

Hopital Nord Franche-Comte

Belfort, Trevenans, 90015, France

Location

Hopital Rothschild - AP-HP

Paris, Île-de-France Region, 75012, France

Location

Department od Dermatology, Venerology and Allergology, University of Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Gemeinschaftspraxis Drees.K.CH.Busch/v.d.Ecken

Dortmund, 44137, Germany

Location

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik fuer Dermatologie

Dresden, 01307, Germany

Location

University Hospital Erlangen

Erlangen, 91054, Germany

Location

Oberhausen Sterkrade (Zweigpraxis)

Oberhausen, 46145, Germany

Location

Bugat Pal Korhaz

Gyöngyös, Heves County, 3200, Hungary

Location

DermaMed Research Kft

Orosháza, Oroshaza, 5900, Hungary

Location

Clinexpert Kft

Budapest, 1033, Hungary

Location

Debreceni Egyetem, Klinikai Kozpont, Borgyogyaszati Klinika

Debrecen, 4002, Hungary

Location

Markhot Ferenc oktatókórház és rendelöintézet

Eger, 3300, Hungary

Location

BKS Research Kft

Hatvan, 3000, Hungary

Location

Uslugi Medyczne PRO-MED Sp. z.o.o

Gliwice, Gliwicie, 44109, Poland

Location

Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy Poradnia Leczenia Ran Przewleklych

Bydgoszcz, 85-094, Poland

Location

Nzoz Gam-Med

Kielce, 25315, Poland

Location

MIKOMED Sp. Z.o.o.

Lodz, 94238, Poland

Location

Braci Wieniawskick 12B

Lublin, 20-844, Poland

Location

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

Accelerate CIC

London, E8 4SA, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Vice President Corporate Clinical & Medical Affairs CMO & RQA
• Organization: Mölnlycke

jane.clark@molnlycke.com

+46317223045

Study Officials

• Joachim Dissemond, Professor Dr.

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Wound closure (CCC and PCC) will be assessed through ulcer photos by 2 independent and experienced clinicians unaware of treatment allocation (blind review).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentre, prospective, randomized, European open label, assessor blinded, 2-arm parallel group study.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 29, 2019
• Study Start: June 8, 2020
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5); FR (3); GB (2); CZ (3); CR (3); DE (5); HU (6)