Trial Outcomes & Findings for Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment (NCT NCT02184455)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

4 weeks

Results posted on

2019-09-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DermGEN Decellularized Dermal Matrix n=11 Participants 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.
Age, Continuous	61 years STANDARD_DEVIATION 13 • n=11 Participants
Sex: Female, Male Female	1 Participants n=11 Participants
Sex: Female, Male Male	10 Participants n=11 Participants
Region of Enrollment Canada	11 participants n=11 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DermGEN Decellularized Dermal Matrix n=10 Participants 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.
Percentage of Wound Area Reduction Compared to Baseline	87 percentage of wound closure Standard Error 18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DermGEN Decellularized Dermal Matrix n=10 Participants 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.
Percentage of Patients With Complete Healing at Any Time Point	9 Participants

SECONDARY outcome

Timeframe: 20 weeks

Reporting the number of patients participating in the study having adverse events

Outcome measures

Outcome measures
Measure	DermGEN Decellularized Dermal Matrix n=10 Participants 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.
Number of Patients With Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: These are the number of patients that had their ulcer healed within the 20 weeks of the study.

Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment.

Outcome measures

Outcome measures
Measure	DermGEN Decellularized Dermal Matrix n=9 Participants 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.
Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing	9 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DermGEN Decellularized Dermal Matrix n=10 Participants 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.
Percent Change in Wound Size Compared to Baseline	92 percentage from baseline Standard Error 22

SECONDARY outcome

Timeframe: 12 Weeks

change in area of wound in percent from initial presentation

Outcome measures

Outcome measures
Measure	DermGEN Decellularized Dermal Matrix n=10 Participants 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.
Percent Change in Wound Area From Baseline	97 percentage of change from baseline Standard Error 9

Adverse Events

DermGEN Decellularized Dermal Matrix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul F. Gratzer, CSO

DeCell Technolpogies Inc.

Phone: 902-223-2179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place