Trial Outcomes & Findings for Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) (NCT NCT03312595)

NCT ID: NCT03312595

Last Updated: 2025-09-16

Results Overview

from baseline at week 0 to 14 weeks

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Up to 14 weeks
• Results posted on: 2025-09-16

Participant Flow

Participant milestones

Measure	Restrata Wound Matrix Prospective, single armed, non-randomized study with direct assignment Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds
Overall Study STARTED	30
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data not consistently reported for all patients

Baseline characteristics by cohort

Measure	Restrata Wound Matrix n=24 Participants Prospective, single armed, non-randomized study with direct assignment Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds
Age, Categorical <=18 years	0 Participants n=20 Participants • Data not consistently reported for all patients
Age, Categorical Between 18 and 65 years	19 Participants n=20 Participants • Data not consistently reported for all patients
Age, Categorical >=65 years	1 Participants n=20 Participants • Data not consistently reported for all patients
Sex: Female, Male Female	2 Participants n=20 Participants • Data not consistently reported for all patients
Sex: Female, Male Male	18 Participants n=20 Participants • Data not consistently reported for all patients

PRIMARY outcome

Timeframe: Up to 14 weeks

from baseline at week 0 to 14 weeks

Outcome measures

Measure	Restrata Wound Matrix n=24 Participants Prospective, single armed, non-randomized study with direct assignment Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds
Percentage of Participants With Wound Closed	75 percentage of participants

SECONDARY outcome

Timeframe: Baseline and weekly for up to 14 weeks

Wound area measurements will be made via tracing acetate every week for 14 weeks.

Outcome measures

Measure	Restrata Wound Matrix n=24 Participants Prospective, single armed, non-randomized study with direct assignment Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds
Change in Wound Area From Baseline	96 % wound area change Standard Deviation 10

SECONDARY outcome

Timeframe: Baseline up to 14 weeks

The number of weeks until complete closure is first identified will be determined for each patient who has been deemed completely closed within the 14 week treatment period.

Outcome measures

Measure	Restrata Wound Matrix n=18 Participants Prospective, single armed, non-randomized study with direct assignment Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds
Time to Wound Closure	6.4 weeks Standard Deviation 2.5

Adverse Events

Restrata Wound Matrix

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Restrata Wound Matrix n=24 participants at risk Prospective, single armed, non-randomized study with direct assignment Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds
General disorders Fever	4.2% 1/24 • 3.5 months
General disorders Infection	12.5% 3/24 • 3.5 months
General disorders Trauma	8.3% 2/24 • 3.5 months
General disorders Osteomyelitis	8.3% 2/24 • 3.5 months
General disorders Peripheral vascular disease	4.2% 1/24 • 3.5 months
General disorders Blister	8.3% 2/24 • 3.5 months
General disorders New ulcer	4.2% 1/24 • 3.5 months

Additional Information

Chief Science Officer

Acera Surgical, Inc.

Phone: 844-879-2237

Email: information@acera-surgical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60