Trial Outcomes & Findings for A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers (NCT NCT01858545)

Last Updated: 2021-04-15

Results Overview

Number of participants with incidence of complete wound closure

Recruitment status

TERMINATED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

8 Weeks

Results posted on

2021-04-15

Participant milestones
Measure	Experimental MatriStem MicroMatrix and MatriStem Wound Matrix MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix	Comparator Cellular Dermal Replacement Tissue Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue
Overall Study STARTED	27	29
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	4	6

Withdrawal data not reported

A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

Baseline characteristics by cohort
Measure	Experimental n=27 Participants MatriStem MicroMatrix and MatriStem Wound Matrix MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix	Comparator n=29 Participants Cellular Dermal Replacement Tissue Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue	Total n=56 Participants Total of all reporting groups
Age, Continuous	57 Years STANDARD_DEVIATION 9.8 • n=5 Participants	58.5 Years STANDARD_DEVIATION 11.4 • n=7 Participants	57.6 Years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants

Timeframe: 8 Weeks

Number of participants with incidence of complete wound closure

Outcome measures
Measure	Experimental n=27 Participants MatriStem MicroMatrix and MatriStem Wound Matrix MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix	Comparator n=29 Participants Cellular Dermal Replacement Tissue Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue
Number of Participants With Complete Wound Closure	5 Participants	2 Participants

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events
Measure	Experimental n=27 participants at risk MatriStem MicroMatrix and MatriStem Wound Matrix MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix	Comparator n=29 participants at risk Cellular Dermal Replacement Tissue Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue
Gastrointestinal disorders Enteritis	3.7% 1/27	0.00% 0/29
Gastrointestinal disorders Rectal Hemorrhage	3.7% 1/27	0.00% 0/29
Infections and infestations Cellulitis	11.1% 3/27	0.00% 0/29
Infections and infestations Localized Infection	7.4% 2/27	0.00% 0/29
Infections and infestations Osteomyelitis	3.7% 1/27	0.00% 0/29
Infections and infestations Pneumonia	3.7% 1/27	0.00% 0/29
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/27	3.4% 1/29
Infections and infestations Urinary Tract Infection	0.00% 0/27	3.4% 1/29
Injury, poisoning and procedural complications Wound	0.00% 0/27	3.4% 1/29
Musculoskeletal and connective tissue disorders Flank Pain	3.7% 1/27	0.00% 0/29
Nervous system disorders Cerebrovascular Accident (Death)	3.7% 1/27	0.00% 0/29

Other adverse events
Measure	Experimental n=27 participants at risk MatriStem MicroMatrix and MatriStem Wound Matrix MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix	Comparator n=29 participants at risk Cellular Dermal Replacement Tissue Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue
Infections and infestations Wound Infection	3.7% 1/27	6.9% 2/29

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