Diabetes Type I, Diabetes Type II
Conditions
Keywords
Diabetic, Chronic Ulcer, Wound Healing, Leg
Brief 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. 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.
Interventions
BIOLOGICALDermGEN
DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.
Sponsors
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority
Dr. Paul F. Gratzer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Diabetic type I/II patients with chronic ulcer present
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A subject will be considered eligible to participate in this study if each of the following inclusion criteria is satisfied: 1. Patient with documented stable Type I or II diabetes (HbA1C \>7.0 within 1 month prior to Day 0). 2. Patient's ulcer has been present for a minimum of 2 weeks as of Day 0. 3. Study ulcer has healed \<30% in size during the 2 weeks prior to Day 0. 4. Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study. 5. Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule. 6. Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0. 7. 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. 8. Female patients are not pregnant at time of, or during study. 9. Patient and caregiver ready and willing to participate and comply with follow-up regime. 10. Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form.
Exclusion criteria
A subject will not be considered eligible to participate in this study if any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Wound Area Reduction Compared to Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Complete Healing at Any Time Point | 20 weeks | 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. |
| Number of Patients With Adverse Events | 20 weeks | Reporting the number of patients participating in the study having adverse events |
| Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing | 1 year | Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment. |
| Percent Change in Wound Size Compared to Baseline | 20 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. Note 100% equals complete closure of the wound. |
| Percent Change in Wound Area From Baseline | 12 Weeks | change in area of wound in percent from initial presentation |
Countries
Canada
Participant flow
Recruitment details
This study was conducted at the Multi-disciplinary Leg Ulcer Clinic at the Queen Elizabeth II Hospital, Halifax, N.S. and Wound Care Clinic at St. Michael's Hospital, Toronto, O.N. The study was initiated on July 1st, 2016 and ended patient enrolment on March 31st, 2017.
Participants by arm
| Arm | Count |
|---|---|
| DermGEN Decellularized Dermal Matrix DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | DermGEN Decellularized Dermal Matrix | — |
|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 13 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 11 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DermGEN Decellularized Dermal Matrix | Percentage of Wound Area Reduction Compared to Baseline | 87 percentage of wound closure | Standard Error 18 |
Secondary
Number of Patients With Adverse Events
Reporting the number of patients participating in the study having adverse events
Time frame: 20 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermGEN Decellularized Dermal Matrix | Number of Patients With Adverse Events | 0 Participants |
Secondary
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.
Time frame: 1 year
Population: These are the number of patients that had their ulcer healed within the 20 weeks of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DermGEN Decellularized Dermal Matrix | Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing | 9 participants |
Secondary
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.
Time frame: 20 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermGEN Decellularized Dermal Matrix | Percentage of Patients With Complete Healing at Any Time Point | 9 Participants |
Secondary
Percent Change in Wound Area From Baseline
change in area of wound in percent from initial presentation
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DermGEN Decellularized Dermal Matrix | Percent Change in Wound Area From Baseline | 97 percentage of change from baseline | Standard Error 9 |
Secondary
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.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DermGEN Decellularized Dermal Matrix | Percent Change in Wound Size Compared to Baseline | 92 percentage from baseline | Standard Error 22 |