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History of Changes for Study: NCT04181320
A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs). (Granulox01)
Latest version (submitted August 23, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 26, 2019 None (earliest Version on record)
2 July 3, 2020 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Study Description and Study Identification
3 September 24, 2020 Study Status, Contacts/Locations and Oversight
4 December 14, 2020 Contacts/Locations and Study Status
5 April 21, 2021 Contacts/Locations and Study Status
6 April 28, 2021 Contacts/Locations and Study Status
7 October 1, 2021 Contacts/Locations and Study Status
8 November 16, 2021 Contacts/Locations and Study Status
9 November 30, 2021 Study Status and Contacts/Locations
10 August 23, 2022 Study Status and Contacts/Locations
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Study NCT04181320
Submitted Date:  November 26, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: PD-568268
Brief Title: A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs). (Granulox01)
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2019
Overall Status: Not yet recruiting
Study Start: December 3, 2019
Primary Completion: September 30, 2022 [Anticipated]
Study Completion: December 31, 2022 [Anticipated]
First Submitted: November 22, 2019
First Submitted that
Met QC Criteria:
November 26, 2019
First Posted: November 29, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
November 26, 2019
Last Update Posted: November 29, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Molnlycke Health Care AB
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

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.
  • Cost-effectiveness.
  • Safety by means of Adverse Events (AE) and Serious Adverse Events (SAE) reporting.
Open or close this module Conditions
Conditions: Venous Leg Ulcer
Keywords: Granulox
venous ulcers
wound healing
wound reduction
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Multicentre, prospective, randomized, European open label, assessor blinded, 2-arm parallel group study.
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 254 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • Granulox
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. Healing time
[ Time Frame: 20 weeks ]

Calculated from time in days from baseline to the first observation of CCC.
2. 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.
3. 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).
4. 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®.
5. Healing trajectories
[ Time Frame: 20 weeks ]

Calculated progression of the re-epithelialization wave over time.
6. 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'
7. 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.
8. 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.
9. 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).
10. 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.
11. 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.
12. 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.
13. 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
14. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 >60 mmHg 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 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.
  9. In case of two 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).

Open or close this module Contacts/Locations
Central Contact Person: Sabrina Chowdhury
Telephone: +44 (0)7769 907654
Email: sabrina.chowdhury@molnlycke.com
Study Officials: Joachim Dissemond, Professor Dr.
Principal Investigator
University Hospital, Essen
Locations: Poland
Braci Wieniawskick 12B
Lublin, Poland, 20-844
Contact:Contact: Piotr Niedziela, Dr
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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