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Decellularized Dermal Matrix
DermGEN™ for Diabetic Foot Ulcers
N/A
Waitlist Available
Led By Paul F Gratzer, Ph.D.
Research Sponsored by DeCell Technologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant willing to wear Total Contact Cast (TCC) for wound off-loading during treatment
Documented stable Type I or II diabetes (HbA1C between 5.0 to 10 mmol/L within 1 month prior to Day 0)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to and including 20 weeks post initial treatment (day 0)
Awards & highlights
Study Summary
This trial will study whether a decellularized dermal matrix can improve wound healing in First Nations people with diabetes.
Who is the study for?
This trial is for First Nations people with Type I or II diabetes and an active diabetic foot ulcer. Participants must be willing to wear a Total Contact Cast, have stable diabetes (HbA1C between 5.0 to 10 mmol/L), and ulcers suitable for skin grafting without deep tissue exposure. Exclusions include non-diabetes-related ulcers, certain medical conditions, immunosuppressant use, cancer not in remission for over 5 years, severe liver disease or infection, pregnancy intention during the study period, smoking habit or known allergies to specific antibiotics.Check my eligibility
What is being tested?
The trial compares standard wound care against the application of DermGEN™ - a decellularized dermal matrix on diabetic foot ulcers among First Nations individuals. It's a randomized study where participants are equally divided into two groups: one receiving regular care and the other getting DermGEN™ treatment alongside regular care.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions at the site of application such as redness or irritation from DermGEN™ treatment; however these would typically be monitored closely by healthcare providers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to wear a Total Contact Cast for my treatment.
Select...
My diabetes is stable with HbA1C levels between 5.0 to 10 mmol/L.
Select...
My ulcer reaches into the layer beneath my skin but does not expose muscle or bone.
Select...
My ulcer is clean, infection-free, and ready for a skin graft.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to and including 20 weeks post initial treatment (day 0)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to and including 20 weeks post initial treatment (day 0)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Impact of Treatment on Quality of Life (WoundQoL)
Impact of Treatment on Wound - LUMT Score
Incidence of adverse events.
+3 moreSecondary outcome measures
Mean and median reduction in wound area at 12 weeks
Mean and median reduction in wound area at 8 weeks
Proportion with complete healing at any time point
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DermGEN™Experimental Treatment1 Intervention
A decellularized dermal matrix created from donated human skin. This arm will receive the same care as the Standard of Care control arm-physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment-with the addition of DermGEN™ onto the wound at the first visit.
Group II: Standard of CareActive Control1 Intervention
The standard of care includes physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment
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Who is running the clinical trial?
Dalhousie UniversityOTHER
167 Previous Clinical Trials
403,018 Total Patients Enrolled
Lakehead UniversityOTHER
24 Previous Clinical Trials
3,873 Total Patients Enrolled
DeCell Technologies Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to wear a Total Contact Cast for my treatment.My diabetes is stable with HbA1C levels between 5.0 to 10 mmol/L.I am willing to take care of my treatment needs at home.I am currently pregnant or plan to become pregnant during the study.My ulcer has been present for at least 2 weeks.The size of the ulcer is 2 square centimeters or larger before cleaning on the first day of the study.My ulcer is not caused by diabetes.I am currently on or might need immunosuppressant medication.My cancer has not been in remission for 5+ years.My ulcer reaches into the layer beneath my skin but does not expose muscle or bone.My ulcer is clean, infection-free, and ready for a skin graft.I have liver disease, hepatitis, anemia, low albumin, or high alkaline phosphatase/LDH levels.I have an untreated infection or an autoimmune disorder affecting my tissues.I am currently receiving chemotherapy or radiation therapy.I am able to understand and consent to participate in this study.My ulcer has deep tracks that cannot be fully cleaned out.Blood flow to my limbs is confirmed to be good by tests.I received radiation therapy within the last 30 days.I have signs of a serious skin or bone infection.You weigh more than 110 pounds for every 4 feet 11 inches of your height.I have an ulcer over a foot and ankle deformity due to diabetes.I have a bleeding disorder or am on blood thinners.You smoke at least one cigarette every day.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: DermGEN™
- Group 2: Standard of Care
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I able to partake in this clinical research?
"Aspirants to this research study should meet two criteria: diabetes mellitus and being between 18-80 years old. A maximum of 120 individuals can join the trial."
Answered by AI
What improvements is this clinical trial expected to yield?
"As reported by DeCell Technologies Inc., the primary efficacy measure for this study will be a LUMT Score taken over an 8-week period. Furthermore, secondary outcomes including the proportion of wounds healed at any given time and mean/median reduction in wound area at both 8 and 12 weeks intervals are also being monitored."
Answered by AI
Are there still opportunities to partake in this scientific investigation?
"A review of clinicaltrials.gov reveals that, as of 7/26/2022, this trial is not accepting any recruits. Originally published on 12/30/2022, there are presently 2275 other studies recruiting patients."
Answered by AI
Is it permissible to include persons aged forty and above in this trial?
"The eligibility requirements of this trial stipulate that participants must be above the age of consent and below 80 years old."
Answered by AI
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