Venous UlcerPhase 3NCT02845466
Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
A Phase 3 study testing Becaplermin and Promagran Dressing in people with Venous Ulcer and Foot Ulcer, Diabetic, run by McMaster University at 1 site in Canada.
Trial summary
Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Venous Ulcer, Foot Ulcer, Diabetic
- What is being tested?
- Becaplermin and Promagran Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2018to Sep 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥18 years
- Ulcer size 1-64 cm²
- Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone
- Ulcer duration >3 months
- Ulcer located between and including the knee and ankle
- For venous leg ulcers - Venous refilling time <25s on photoplethysmography or abnormal venous insufficiency Duplex scan
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- For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a haemoglobin A1C < 12%
- Wounds have not been treated with Promogran in the previous 4 weeks
- Patients able to give informed consent
Who cannot join
- Ankle-brachial index <0.8
- Ulcer with local or systemic signs of infection
- Patients who have been previously treated with Becaplermin gel
- Receiving corticosteroids or immune suppressants
- History of autoimmune disease
- Uncontrolled diabetes (baseline haemoglobin A1C > 12%)
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- Severe rheumatoid arthritis
- Uncontrolled congestive heart failure
- Malnutrition (albumin <2.5g/dL)
- Unable to adhere to the protocol
- Known sensitivities to the wound dressings used in the trial
- A history of any previous malignancy
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Steve Phillips, MSc, 905-521-2100 ext. 44167, phills3@mcmaster.ca
About this study
Official title: Proof of Concept Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.
- Conditions
- Venous Ulcer, Foot Ulcer, Diabetic
- Being tested
- Becaplermin, Promagran Dressing, Placebo Dressing
- Keywords
- Venous Leg Ulcer, Diabetic Foot Ulcer, Wound Healing, Growth Factor, Protease Inhibitor
- Medical subject headings
- Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BecaplerminBiological
Also called Regranex
0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.
Promagran DressingDevice
44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.
Placebo DressingDevice
Also called Aquacel
Inactive wound dressing.
| Study group | Role | What they receive |
|---|---|---|
| Becaplermin/Promagran Dressing | Experimental | Topical Becaplermin with a protease inhibitor wound dressing. Receives: Biological: Becaplermin; Device: Promagran Dressing |
| Becaplermin/Placebo Dressing | Active comparator | Topical Becaplermin with a placebo wound dressing. Receives: Biological: Becaplermin; Device: Placebo Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Applied Growth Factors in Chronic Wound Fluid
The levels of the growth factors applied to the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.
Measured: 6 weeks
Secondary outcomes (4)
Protease Levels in Chronic Wound Fluid
The levels of enzyme activity in the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.
Measured: 6 weeks
Chronic Wound Healing at 4 Weeks
Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.
Measured: 4 weeks
WOUNDCHEK Device Validity
The WOUNDCHEK device will be used in order to test for levels of enzyme activity in the chronic wound. This data will then be compared to the enzyme activity as determined by the levels analyzed in the chronic wound fluid.
Measured: 6 weeks
Levels of Healing Biomarkers in Chronic Wound Fluid
The levels of the potential biomarker of healing GMCSF in the chronic wound fluid will be measured using samples of the chronic wound fluid collected at the first two visits each week.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startAug 2018 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Michael Stacey, MBBS, Doctor of Surgery, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845466
- Sponsor's protocol ID
- Lower Limb Ulcer Topical Ther
- Status last verified
- Apr 2018
- First submitted
- 14 Jul 2016
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stacey M. Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing: Protocol for a Randomized Controlled Proof-of-Concept Study. JMIR Res Protoc. 2018 Apr 27;7(4):e97. doi: 10.2196/resprot.8327.
PubMed 29703712
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
- ClinicalTrials.gov ID
- NCT02845466
- Acronym / sponsor ID
- Lower Limb Ulcer Topical Ther
- Conditions
- Venous Ulcer, Foot Ulcer, Diabetic
- Keywords
- Venous Leg Ulcer, Diabetic Foot Ulcer, Wound Healing, Growth Factor, Protease Inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2018 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Becaplermin/Promagran Dressing | Experimental | Biological: Becaplermin, Device: Promagran DressingTopical Becaplermin with a protease inhibitor wound dressing. |
| Becaplermin/Placebo Dressing | Active comparator | Biological: Becaplermin, Device: Placebo DressingTopical Becaplermin with a placebo wound dressing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women aged ≥18 years
- Ulcer size 1-64 cm²
- Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone
- Ulcer duration >3 months
- Ulcer located between and including the knee and ankle
Key exclusion criteria (13 listed)
- Ankle-brachial index <0.8
- Ulcer with local or systemic signs of infection
- Patients who have been previously treated with Becaplermin gel
- Receiving corticosteroids or immune suppressants
- History of autoimmune disease
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 |
|---|---|---|
| BecaplerminAlso: Regranex0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks. | Biological | Becaplermin/Placebo Dressing, Becaplermin/Promagran Dressing |
| Promagran Dressing44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks. | Device | Becaplermin/Promagran Dressing |
| Placebo DressingAlso: AquacelInactive wound dressing. | Device | Becaplermin/Placebo Dressing |
Primary outcome
Level of Applied Growth Factors in Chronic Wound Fluid
Time frame: 6 weeks
The levels of the growth factors applied to the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.
4 secondary outcomes
Protease Levels in Chronic Wound Fluid
Time frame: 6 weeks
Chronic Wound Healing at 4 Weeks
Time frame: 4 weeks
WOUNDCHEK Device Validity
Time frame: 6 weeks
Levels of Healing Biomarkers in Chronic Wound Fluid
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Derived from this study: PubMed 29703712Stacey M. Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing: Protocol for a Randomized Controlled Proof-of-Concept Study. JMIR Res Protoc. 2018 Apr 27;7(4):e97. doi: 10.2196/resprot.8327.
- Individual participant dataSharing planned: No
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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.
Michael Stacey, MBBS, Doctor of Surgery principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Becaplermin and Promagran Dressing in people with Venous Ulcer and Foot Ulcer, Diabetic, run by McMaster University at 1 site in Canada.
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 9 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: status not confirmed, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Phillips, MSc (905-521-2100 ext. 44167, phills3@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Applied Growth Factors in Chronic Wound Fluid (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02845466, which also lists 1 linked publication.
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 9 Apr 2018.