Trial Outcomes & Findings for Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers (NCT NCT03476876)

Results Overview

Wound area in squared centimeters will be quantified using Aranz Medical Image processing system. The wound will be manually traced using Aranz Medical to obtain length and width. Then the average of wound per group will be compared at 16 weeks.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

34 participants

Primary outcome timeframe

An average of 16 weeks.

Results posted on

2023-07-07

Participant Flow

Unit of analysis: lesions

Participant milestones

Participant milestones
Measure	Dermacell Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Overall Study STARTED	19 19	15 15
Overall Study COMPLETED	9 9	7 7
Overall Study NOT COMPLETED	10 10	8 8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Receiving Dermacell Acellular Dermal Matrix in One Lesion n=19 Participants Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular dermal matrix. Subject will be followed up to 16 weeks post treatment, or until the wound has closed, whichever comes first.	Participants Receiving Integra Bilayer Cross-linked Matrix in One Lesion n=15 Participants Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	59.5 years STANDARD_DEVIATION 10.1 • n=5 Participants	56.6 years STANDARD_DEVIATION 13.5 • n=7 Participants	59 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: An average of 16 weeks.

Population: one lesion per subject was analyzed. Data from 18 subjects was unable to be collected at last follow up visit due to drop out of the study.

Wound area in squared centimeters will be quantified using Aranz Medical Image processing system. The wound will be manually traced using Aranz Medical to obtain length and width. Then the average of wound per group will be compared at 16 weeks.

Outcome measures

Outcome measures
Measure	Dermacell n=9 lesions Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra n=7 lesions Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Wound Area at 16 Weeks	6.1 cm^2 Standard Deviation 6.5	6.8 cm^2 Standard Deviation 8

PRIMARY outcome

Timeframe: An average of 16 weeks.

Population: One lesion per participant will be analyzed. Data from 18 subjects was unable to be collected due to drop out of the study.

Percentage of wound granulation will be subjectively assessed based on the observation and criteria of the treating clinician. After cleaning the wound, the clinician will provide with a percentage of granulated tissue based on his/her observation. Then, the average of wound granulation per group will be compared at 16 weeks

Outcome measures

Outcome measures
Measure	Dermacell n=9 lesions Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra n=7 lesions Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Percentage of Wound Granulation at 16 Weeks	80.44 percentage of wound granulation Standard Deviation 31.5	96.7 percentage of wound granulation Standard Deviation 5.1

PRIMARY outcome

Timeframe: An average of 16 weeks.

Population: One leg (which contains the lesion) per patient was analyzed. Data from 18 subjects was unable to be collected due to drop out of the study. Data from the resting 14 subjects was unable to be collected at last follow up visit due to patient comfortability, lower extremity manipulation, risk for infection, or device component (sensors) discontinuation.

Skin perfusion will be quantified by Skin Perfusion Pressure Test (SPP) using Sensilase PAD-IQ (VASAMED) on the lower extremities. This tests utilizes a cuff with sensors placed above the ankle level which measures the lower extremity distal skin perfusion pressure in millimeters of mercury (mmHg) while eliciting and releasing pressure to the vasculature of the lower leg through the cuff. Then, the average of mmHg per group will be compared at 16 weeks.

Outcome measures

Outcome measures
Measure	Dermacell n=2 legs Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Lower Extremity Skin Perfusion at 16 Weeks	62.5 mmHg Standard Deviation 13.4	—

PRIMARY outcome

Timeframe: An average of 16 weeks.

Population: One lesion per participant was analyzed. Data from 18 subjects was unable to collect due to drop out of study. Data from the resting 1 subject was unable to be collected at last follow up visit due to patient non-compliance.

Wound saturation of oxygen will be quantified using Near Infrared Spectroscopy by Kent Imaging system. Kent is a non-invasive camera that detects wound saturation of oxygen with a simple spectral picture. After taking the picture, each wound will be traced allowing for accurate and detailed data collection. Then, the average of saturation of oxygen of wounds per group will be compared at 16 weeks.

Outcome measures

Outcome measures
Measure	Dermacell n=8 lesions Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra n=7 lesions Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Wound Saturation of Oxygen at 16 Weeks	65.5 percentage of saturation of oxygen Standard Deviation 22.8	83.1 percentage of saturation of oxygen Standard Deviation 8.1

SECONDARY outcome

Timeframe: Only baseline, time of recruitment

Frailty assessment will be measured with the Trauma Specific Frailty Index (TSFI) score. The total score of 15 variables including cardiovascular and cognitive comorbidities, and features such as mobility assistance, mood status, physical function, and nutritional status will be taken into consideration to determine whether a patient is frail. The minimum score is 0 and the maximum score is 0.3. A total score (including the 15 variables) of \>0.27 is considered as frail. A score of ≤0.27 score is considered as non-frail.

Outcome measures

Outcome measures
Measure	Dermacell n=19 Participants Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra n=15 Participants Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Number of Participants With Frailty	11 Participants	8 Participants

SECONDARY outcome

Timeframe: Only at baseline, time of recruitment

Population: All patients received a graft at the study enrollment. Therefore, the average time of graft placement was obtained from all the subjects at baseline.

Duration of graft application will be measured from the time of the graft being placed on the wound, to the time of the last suture/staple to secure the graft placement. Time will be counted in seconds. Then, the average of time per group will be compared to the other group.

Outcome measures

Outcome measures
Measure	Dermacell n=19 grafts Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra n=15 grafts Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Time of Graft Application to One Wound During Baseline Procedure	879.1 seconds Standard Deviation 501.8	667.5 seconds Standard Deviation 561.4

SECONDARY outcome

Timeframe: An average of 16 weeks.

Number of participants in need to re-apply at least one same or different graft(s) to one wound in approximately 16 weeks

Outcome measures

Outcome measures
Measure	Dermacell n=9 Participants Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra n=7 Participants Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Number of Participants With Graft Re-application to One Wound at 16 Weeks	3 Participants	0 Participants

SECONDARY outcome

Timeframe: An average of 16 weeks.

Complication is described as infection, necrosis, bleeding, or graft-rejection of one wound per patient.

Outcome measures

Outcome measures
Measure	Dermacell n=19 Participants Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.	Integra n=15 Participants Subject will receive treatment for one non-healing deep diabetic foot ulcer using Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound closure, whichever comes first.
Number of Participants With Wound Complications at 16 Weeks	10 Participants	8 Participants

Adverse Events

Dermacell

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Integra

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

Prof. Bijan Najafi

Baylor College of Medicine

Phone: 7137987536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60