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

NCT ID: NCT04181320

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2023-01-17

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.

Detailed Description

The current study is designed to verify previous clinical findings and to pinpoint clinically relevant efficacy, associated to intended use of Granulox® as a therapy added to a defined standard of care in the management of chronic VLUs. The most relevant outcome is considered to be an increase in healing of chronic VLUs over a period of 20 weeks.

This is a multi-centre European open label randomised 2-arm parallel group study. The study will include multiple European counties (e.g. France, Germany, UK, Poland, Croatia and Czech Republic), with approximately 2-7 clinics per country.

The study will run with a two-phase set-up, with a 14 days run-in period and a an up to 20 weeks treatment period starting with randomization and allocation of treatment. Confirmation of wound closure is further assessed after a 15 day followup period.

The primary objective of the study is to compare wound healing between management of chronic VLUs with or without added Granulox®. The main efficacy criterion is Confirmed Complete wound Closure (CCC).

Conditions

Venous Leg Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Venous Leg Ulcer Standard of Care

Subjects will recieve standard of care treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Venous Leg Ulcer Standard of Care with Granulox

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

Group Type: EXPERIMENTAL

Venous Leg Ulcer Standard of Care with Granulox

Intervention Type: DEVICE

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

Interventions

Venous Leg Ulcer Standard of Care with Granulox

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

Intervention Type: DEVICE

Other Intervention Names

Granulox

Eligibility Criteria

Inclusion Criteria

1. Signed consent to participate.

2. No planned hospitalization in the forthcoming 20 weeks.

3. Male or female (women of childbearing age must have an acceptable method of birth control).

4. Age >18 years.

5. Recent (less than 12 months) doppler or duplex colour ultrasonography compatible with chronic venous insufficiency.

6. 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.

7. At least one or more supra- or peri-malleolar leg ulcers and no foot ulcer or another chronic wound.

8. 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).

9. 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.

10. Wound duration ≥ 8 weeks and ≤60 months.

11. 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.

12. Less than 50% of the wound area should be covered with fibrinous tissue at randomization and after debridement.

13. 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).

14. No clinically significant comorbidities requiring the use of systemic steroids or any cytotoxic or immunosuppressive agents.

Exclusion Criteria

1. 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.

2. Circumferential wounds.

3. Wound covered fully or partially by necrotic tissue (black tissue).

4. Patients who will have problems following the protocol, especially compression therapy.

5. Patients included in another on-going clinical investigation, or patients who have participated in a clinical investigation during the past 30 days.

6. 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.

7. Patient with a systemic infection not controlled by suitable antibiotic treatment.

8. Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids (>10 mg Predinsolone or equivalent) if any.

9. Patient with deep vein thrombosis within 3 months prior to inclusion.

10. Known allergy/hypersensitivity to the ingredients of the dressings and/or Granulox®.

11. Malignant wounds.

12. Endovenous surgery planned or performed within the past 30 days.

13. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Dissemond, Professor Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

Klinicki odjel za vaskularnu kirurgiju

Split, , Croatia

University Hospital Dubrava

Zagreb, , Croatia

Zavod za vaskularnu kirurgiju

Zagreb, , Croatia

Salvatella s.r.o.

Třinec, Dolni Lomna, Czechia

CHIR-Chirurgické oddeleni

Jihlava, , Czechia

U Nemocnice v Praze

Prague, , Czechia

Hopital Michallon

Grenoble, La Tronche, France

Hopital Nord Franche-Comte

Belfort, Trevenans, France

Hopital Rothschild - AP-HP

Paris, Île-de-France Region, France

Department od Dermatology, Venerology and Allergology, University of Essen

Essen, North Rhine-Westphalia, Germany

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

Dortmund, , Germany

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

Dresden, , Germany

University Hospital Erlangen

Erlangen, , Germany

Oberhausen Sterkrade (Zweigpraxis)

Oberhausen, , Germany

Bugat Pal Korhaz

Gyöngyös, Heves County, Hungary

DermaMed Research Kft

Orosháza, Oroshaza, Hungary

Clinexpert Kft

Budapest, , Hungary

Debreceni Egyetem, Klinikai Kozpont, Borgyogyaszati Klinika

Debrecen, , Hungary

Markhot Ferenc oktatókórház és rendelöintézet

Eger, , Hungary

BKS Research Kft

Hatvan, , Hungary

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

Gliwice, Gliwicie, Poland

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

Bydgoszcz, , Poland

Nzoz Gam-Med

Kielce, , Poland

MIKOMED Sp. Z.o.o.

Lodz, , Poland

Braci Wieniawskick 12B

Lublin, , Poland

Hull University Teaching Hospitals NHS Trust

Hull, , United Kingdom

Accelerate CIC

London, , United Kingdom

Countries

Croatia; Czechia; France; Germany; Hungary; Poland; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Granulox01 (PD-568268)

Identifier Type: -

Identifier Source: org_study_id