Venous Leg UlcerGranulox01NCT04181320
A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).
A study of Venous Leg Ulcer, run by Molnlycke Health Care AB at 27 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 8 Jun 2020to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
- Patient with deep vein thrombosis within 3 months prior to inclusion.
- 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).
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
Hungary6 sites
Clinexpert Kft
Budapest, 1033
Debreceni Egyetem, Klinikai Kozpont, Borgyogyaszati Klinika
Debrecen, 4002
Markhot Ferenc oktatókórház és rendelöintézet
Eger, 3300
Bugat Pal Korhaz
Gyöngyös, Heves County, 3200
BKS Research Kft
Hatvan, 3000
DermaMed Research Kft
Orosháza, Oroshaza, 5900
Germany5 sites
Gemeinschaftspraxis Drees.K.CH.Busch/v.d.Ecken
Dortmund, 44137
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik fuer Dermatologie
Dresden, 01307
University Hospital Erlangen
Erlangen, 91054
Department od Dermatology, Venerology and Allergology, University of Essen
Essen, North Rhine-Westphalia, 45147
Oberhausen Sterkrade (Zweigpraxis)
Oberhausen, 46145
Poland5 sites
Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy Poradnia Leczenia Ran Przewleklych
Bydgoszcz, 85-094
Uslugi Medyczne PRO-MED Sp. z.o.o
Gliwice, Gliwicie, 44109
Nzoz Gam-Med
Kielce, 25315
MIKOMED Sp. Z.o.o.
Lodz, 94238
Braci Wieniawskick 12B
Lublin, 20-844
Croatia3 sites
Klinicki odjel za vaskularnu kirurgiju
Split, 21000
University Hospital Dubrava
Zagreb, 10000
Zavod za vaskularnu kirurgiju
Zagreb, 10000
Czechia3 sites
CHIR-Chirurgické oddeleni
Jihlava, 58633
U Nemocnice v Praze
Prague, 12808
Salvatella s.r.o.
Třinec, Dolni Lomna, 739 61
France3 sites
Hopital Nord Franche-Comte
Belfort, Trevenans, 90015
Hopital Michallon
Grenoble, La Tronche, 38700
Hopital Rothschild - AP-HP
Paris, Île-de-France Region, 75012
United Kingdom2 sites
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
Accelerate CIC
London, E8 4SA
About this study
Official title: Multicentre, Prospective, Randomized, Open-label, Assessor Blinded Study to Evaluate Granulox® Used as Adjunct Therapy to Defined Standard of Care vs. Defined Standard of Care for the Treatment of Predominantly Chronic Venous Leg Ulcers (VLUs)
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.
Read the 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
- Being tested
- Venous Leg Ulcer Standard of Care with Granulox
- Keywords
- Granulox, venous ulcers, wound healing, wound reduction
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Leg Ulcer Standard of Care with GranuloxDevice
Also called Granulox
Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Venous Leg Ulcer Standard of Care with Granulox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 20 weeks post therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start8 Jun 2020
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Why it stopped: Results of interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, prospective, randomized, European open label, assessor blinded, 2-arm parallel group study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim Dissemond, Professor Dr., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181320
- Sponsor's protocol ID
- Granulox01 (PD-568268)
- Acronym
- Granulox01
- Status last verified
- Aug 2024
- First submitted
- 22 Nov 2019
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Prospective, Randomized, Open-label, Assessor Blinded Study to Evaluate Granulox® Used as Adjunct Therapy to Defined Standard of Care vs. Defined Standard of Care for the Treatment of Predominantly Chronic Venous Leg Ulcers (VLUs)
- ClinicalTrials.gov ID
- NCT04181320
- Acronym / sponsor ID
- Granulox01 / Granulox01 (PD-568268)
- Conditions
- Venous Leg Ulcer
- Keywords
- Granulox, venous ulcers, wound healing, wound reduction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of interim analysis
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, prospective, randomized, European open label, assessor blinded, 2-arm parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Venous Leg Ulcer Standard of Care | No intervention | –Subjects will recieve standard of care treatment. |
| Venous Leg Ulcer Standard of Care with Granulox | Experimental | Device: Venous Leg Ulcer Standard of Care with GranuloxSubjects will recieve standard of care treatment with Granulox added as an adjunct therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous Leg Ulcer Standard of Care with GranuloxAlso: GranuloxGranulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers. | Device | Venous Leg Ulcer Standard of Care with Granulox |
Primary outcome
Confirmed Complete Wound Closure
Time frame: Up to 20 weeks post therapy initiation
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Venous Leg Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Dissemond, Professor Dr. principal investigator
University Hospital, Essen
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Venous Leg Ulcer, run by Molnlycke Health Care AB at 27 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Hungary, Germany, Poland, Croatia, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Complete Wound Closure (time frame: Up to 20 weeks post therapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.