Diabetes Type IPhase 1NCT02184455
Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment
A Phase 1 study testing DermGEN in people with Diabetes Type I and Diabetes Type II, run by Dr. Paul F. Gratzer at 2 sites in Canada.
Trial summary
The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type I, Diabetes Type II
- What is being tested?
- DermGEN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jul 2016to 1 May 2017
- Phase
- Phase 1
- 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
- A subject will be considered eligible to participate in this study if each of the following inclusion criteria is satisfied:
- Patient with documented stable Type I or II diabetes (HbA1C >7.0 within 1 month prior to Day 0).
- Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.
- Study ulcer has healed <30% in size during the 2 weeks prior to Day 0.
- Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.
- Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule.
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- Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0.
- Patient has adequate circulation to the foot as evidenced by palpable pulse or pulse detectable with Doppler ultrasound, and lack of visible cyanosis in skin bordering the ulcer.
- Female patients are not pregnant at time of, or during study.
- Patient and caregiver ready and willing to participate and comply with follow-up regime.
- Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form.
Who cannot join
- A subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied:
- Evidence of gangrene on affected foot.
- Ulcer is over Charcot deformity (fractures or dislocation).
- Ulcer is non-diabetic in etiology.
- Ulcer has tunnels or sinus tracts that cannot be completely debrided.
- Medical condition(s) that in the Investigator's opinion make the patient inappropriate for study
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- Patient has/had malignant disease not in remission for 5 years or more
- Patient has acute or chronic hepatitis, cirrhosis, serum albumin <2.0 gm/dL, or has alkaline phosphatase or LDH at twice the normal upper limit
- Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study
- Patient received radiation therapy within 30 days of Day 0 of study
- Patient has AIDS or is infected with HIV
- Patient has participated in another study using investigational drug(s) or device within the previous 30 days
- Obvious clinical signs and symptoms of ongoing cellulitis or osteomyelitis
- Patient has any other condition which seriously compromises their ability to complete the study
- Patient has known allergies to antibiotics, such as penicillin and streptomycin
- Patient has a history of bleeding disorder
- Patient received elective osseous procedures to the study foot within 30 days prior to screening visit, except that patients whose DFU overlies an area of treated osteomyelitis may be included, providing there exists a suitable base for application of the DermGEN.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H3A7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers
The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will result in positive healing outcomes with no significant adverse effects.
Read the detailed description
This will be a one-arm prospective study. This study in Halifax will be mirrored in one other participating health care center in Toronto, Ontario, Canada with each centre anticipated to enrol 5-10 patients for a total of 15-20 patients.
- Conditions
- Diabetes Type I, Diabetes Type II
- Being tested
- DermGEN
- Keywords
- Diabetic, Chronic Ulcer, Wound Healing, Leg
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermGENBiological
DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.
| Study group | Role | What they receive |
|---|---|---|
| DermGEN Decellularized Dermal Matrix | Experimental | DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue. Receives: Biological: DermGEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Wound Area Reduction Compared to Baseline
Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.
Measured: 4 weeks
Secondary outcomes (5)
Percentage of Patients With Complete Healing at Any Time Point
Complete healing is defined as 100% epithelialization without drainage. Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.
Measured: 20 weeks
Number of Patients With Adverse Events
Reporting the number of patients participating in the study having adverse events
Measured: 20 weeks
Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing
Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment.
Measured: 1 year
Percent Change in Wound Size Compared to Baseline
Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100. Note 100% equals complete closure of the wound.
Measured: 20 weeks
Percent Change in Wound Area From Baseline
change in area of wound in percent from initial presentation
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start1 Jul 2016
- Primary completion1 May 2017
- Study completion1 May 2017
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 Diabetes Type IStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diabetic type I/II patients with chronic ulcer present
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Paul F. Gratzer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Canadian Institutes of Health Research (CIHR), Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Dr. Paul F. Gratzer, DeCell Technologies Inc.
- Investigators
- Mark Glazebrook, PhD,MD, Principal investigator, Queen Elizabeth II Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184455
- Sponsor's protocol ID
- DeCell-001
- Status last verified
- Sep 2019
- First submitted
- 3 Jul 2014
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02184455
- Acronym / sponsor ID
- DeCell-001
- Conditions
- Diabetes Type I, Diabetes Type II
- Keywords
- Diabetic, Chronic Ulcer, Wound Healing, Leg
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Dr. Paul F. GratzerIndustry (pharma, biotech, devices)
- Collaborators
- Canadian Institutes of Health Research (CIHR), Nova Scotia Health Authority
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Posted 16 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will result in positive healing outcomes with no significant adverse effects.
Detailed description
This will be a one-arm prospective study. This study in Halifax will be mirrored in one other participating health care center in Toronto, Ontario, Canada with each centre anticipated to enrol 5-10 patients for a total of 15-20 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diabetic type I/II patients with chronic ulcer present
| Arm | Type | Receives |
|---|---|---|
| DermGEN Decellularized Dermal Matrix | Experimental | Biological: DermGENDermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A subject will be considered eligible to participate in this study if each of the following inclusion criteria is satisfied:
- Patient with documented stable Type I or II diabetes (HbA1C >7.0 within 1 month prior to Day 0).
- Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.
- Study ulcer has healed <30% in size during the 2 weeks prior to Day 0.
- Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.
Key exclusion criteria (17 listed)
- A subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied:
- Evidence of gangrene on affected foot.
- Ulcer is over Charcot deformity (fractures or dislocation).
- Ulcer is non-diabetic in etiology.
- Ulcer has tunnels or sinus tracts that cannot be completely debrided.
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 |
|---|---|---|
| DermGENDermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue. | Biological | DermGEN Decellularized Dermal Matrix |
Primary outcome
Percentage of Wound Area Reduction Compared to Baseline
Time frame: 4 weeks
Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.
5 secondary outcomes
Percentage of Patients With Complete Healing at Any Time Point
Time frame: 20 weeks
Number of Patients With Adverse Events
Time frame: 20 weeks
Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing
Time frame: 1 year
Percent Change in Wound Size Compared to Baseline
Time frame: 20 weeks
Percent Change in Wound Area From Baseline
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark Glazebrook, PhD,MD principal investigator
Queen Elizabeth II Health Sciences Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DermGEN in people with Diabetes Type I and Diabetes Type II, run by Dr. Paul F. Gratzer at 2 sites 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 11 inclusion and 17 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: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2019). 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?
Percentage of Wound Area Reduction Compared to Baseline (time frame: 4 weeks). 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 24 Sep 2019.