A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs). (Granulox01)
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|ClinicalTrials.gov Identifier: NCT04181320|
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : December 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Venous Leg Ulcer||Device: Venous Leg Ulcer Standard of Care with Granulox||Not Applicable|
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).
Secondary objectives include comparisons of management of chronic VLUs with or without added Granulox® with regards to:
- Wound healing by means of Possible Complete wound Closure (PCC), Wound Area Regression (WAR), time to healing, trajectories, pressure ulcer scale for healing (PUSH) score, and clinical assessment.
- Patient Reported Outcomes (PRO) for health-related quality of life (HRQoL)/quality of life (QoL), pain and pain intensity, and impression of change.
- Acceptability of and compliance to therapy.
- Safety by means of Adverse Events (AE) and Serious Adverse Events (SAE) reporting.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicentre, prospective, randomized, European open label, assessor blinded, 2-arm parallel group study.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Wound closure (CCC and PCC) will be assessed through ulcer photos by 2 independent and experienced clinicians unaware of treatment allocation (blind review).|
|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)|
|Actual Study Start Date :||June 8, 2020|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
No Intervention: Venous Leg Ulcer Standard of Care
Subjects will recieve standard of care treatment.
Experimental: Venous Leg Ulcer Standard of Care with Granulox
Subjects will recieve standard of care treatment with Granulox added as an adjunct therapy.
Device: 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.
Other Name: Granulox
- Rate of complete confirmed wound closure (CCC) will be measured and compared for 254 subjects divided into standard of care versus standard of care with Granulox. [ Time Frame: 20 weeks ]Derived by two blinded quantifications of 100% re-epithelialization by PictZar, 15 days (+/- 3 days) apart.
- Healing time [ Time Frame: 20 weeks ]Calculated from time in days from baseline to the first observation of CCC.
- Wound status [ Time Frame: 20 weeks ]
Wound size measured, i.e. width, length, circumference or perimeter, via PictZar®.
- Exudate amount and nature.
- Tissue (i.e. fibrinous, granulation, epithelisation) type, i.e. area and percentage from total wound.
- Skin condition, i.e. peri-wound, redness/irritation/eczema, maceration, blistering, stripping, trauma.
- Local infection status, i.e. pain, perilesional skin erythema, oedema, malodour, levels of exudate.
- Cleansing specification.
- Debridement specification.
- Wound Area Regression (WAR) [ Time Frame: 20 weeks ]Calculated variables 90WAR (i.e. 90% WAR from baseline, based on wound photos) and 50WAR (i.e. 50% WAR from baseline, based on wound photos).
- Rate of possible confirmed wound closure (PCC) will be measured and compared for 254 subjects divided into standard of care versus standard of care with Granulox. [ Time Frame: 20 weeks ]derived from one measurements of 100% reepithelialization by via PictZar®.
- Healing trajectories [ Time Frame: 20 weeks ]Calculated progression of the re-epithelialization wave over time.
- Pressure Ulcer Scale for Healing tool [ Time Frame: 20 weeks ]Wound changes over time will be captured by the Pressure Ulcer Scale for Healing tool. Total score from 0 to 17 where the lower the score the better the outcome e.g when the wound has closed, score as '0'
- Blind assessment of wound healing [ Time Frame: 20 weeks ]Assessor-blinded clinical verification of CCC and PCC based on patient-series of wound photos assessed by independent and experienced clinicians, unaware of treatment allocation.
- Health related Quality of Life assessment by EQ-5D-5L [ Time Frame: 20 weeks ]Patient report outcome questionnaire to evaluate health and quality of life. The higher the score the better the outcome e.g 100 means the best health.
- Wound specific Quality of Life assessment by Wound-QoL [ Time Frame: 20 weeks ]Patient report outcome questionnaire to evaluate wound specific quality of life. A 5 point scale based on 17 questions of the wound in the last seven days from 'not at all' to 'very much'. The lower the score at 'not at all' the better the outcome e.g my wound hurt (not at all).
- Numerical Rating Scale (NRS) [ Time Frame: 20 weeks ]Patient report outcome questionnaire to evaluate pain. A total score range of 0 - 10. The lower the score the better the outcome e.g 0 is no pain.
- Acceptability of care [ Time Frame: 20 weeks ]Assessment of acceptability of care by means of a 5-item scale (e.g. very poor, poor, average, good, very good) where very good is a better outcome. This will be performed at the final visit only.
- Ease of care [ Time Frame: 20 weeks ]Assessment of ease of care by means of a 5-item scale (e.g. very poor, poor, average, good, very good) where very good is a better outcome. This will be performed at the final visit only.
- Evaluation of patient compliant to venous compression [ Time Frame: 20 weeks ]
Evaluation will be based on a 3 point scale from fully compliance, moderately compliance or no compliance to compression therapy where fully compliance is a better outcome. Compliance to compression therapy will be defined as the following:
- Fully compliance (defined as 7/7 days) = continue in study
- Moderately compromised compliance (defined as 2 or 3 days maximum without compression) = continue in study
- No compliance (defined as >3 without compression) = discontinue from study
- Cost Effectiveness [ Time Frame: 20 weeks ]
Collection of cost parameters such as micro costing and resource utilization will be made in the study. These include:
- Wound care consumables associated with dressings (captured both at site by investigator and in the patient specific diary by the study nurse)
- Frequency of dressings changes (captured both at site by investigator and in the patient specific diary by the study nurse). In addition, reporting of adverse events (i.e. infection and hospitalization) will be used as a basis for economic information together with country-specific costs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181320
|Contact: Sabrina Chowdhury||+44 (0)7769 email@example.com|
|Principal Investigator:||Joachim Dissemond, Professor Dr.||University Hospital, Essen|