Trial Outcomes & Findings for A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers (NCT NCT01013792)

Last Updated: 2024-10-02

Results Overview

A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as \[(Baseline - Week 8)/Baseline\] x 100%.

Recruitment status

TERMINATED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

up to 8 weeks

Results posted on

2024-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Non-adherent Wound Dressing Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)	Tegaderm Matrix Dressing With PHI Technology Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Overall Study STARTED	14	16
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-adherent Wound Dressing Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)	Tegaderm Matrix Dressing With PHI Technology Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Overall Study Study suspended	2	1
Overall Study Adverse Event	0	3
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-adherent Wound Dressing n=14 Participants Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)	Tegaderm Matrix Dressing With PHI Technology n=16 Participants Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)	Total n=30 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 7.06 • n=5 Participants	54.1 years STANDARD_DEVIATION 11.01 • n=7 Participants	56.9 years STANDARD_DEVIATION 9.71 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized White	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Diabetic foot ulcer area	3.1 cm2 n=5 Participants	2.8 cm2 n=7 Participants	2.8 cm2 n=5 Participants
Diabetic foot ulcer age 4-12 weeks	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Diabetic foot ulcer age 13-26 weeks	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Diabetic foot ulcer age 27-52 weeks	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Diabetic foot ulcer age >1-5 years	4 participants n=5 Participants	10 participants n=7 Participants	14 participants n=5 Participants
Diabetic foot ulcer age >5 years	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 8 weeks

Population: All participants that are randomized

Outcome measures

Outcome measures
Measure	Non-adherent Wound Dressing n=14 Participants Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)	Tegaderm Matrix Dressing With PHI Technology n=16 Participants Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit	18.1 percent change of baseline area Interval -70.0 to 100.0	34.2 percent change of baseline area Interval -43.9 to 100.0

Adverse Events

Non-adherent Wound Dressing

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Tegaderm Matrix Dressing With PHI Technology

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non-adherent Wound Dressing n=14 participants at risk Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)	Tegaderm Matrix Dressing With PHI Technology n=16 participants at risk Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Vascular disorders Ischemic event with associate foot infection	0.00% 0/14 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	6.2% 1/16 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Infections and infestations Ulcer/foot infection	7.1% 1/14 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	12.5% 2/16 • Number of events 2 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Cardiac disorders Subendocardial myocardial infarction	0.00% 0/14 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	6.2% 1/16 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
General disorders Death	7.1% 1/14 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	0.00% 0/16 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Renal and urinary disorders Bladder Cancer	7.1% 1/14 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	0.00% 0/16 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up

Other adverse events

Other adverse events
Measure	Non-adherent Wound Dressing n=14 participants at risk Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)	Tegaderm Matrix Dressing With PHI Technology n=16 participants at risk Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	21.4% 3/14 • Number of events 3 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	18.8% 3/16 • Number of events 3 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Infections and infestations Wound/Skin Infection	28.6% 4/14 • Number of events 8 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	43.8% 7/16 • Number of events 9 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Skin and subcutaneous tissue disorders Pain, Trauma, Blister	35.7% 5/14 • Number of events 7 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	37.5% 6/16 • Number of events 8 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Vascular disorders Phlebitis, Edema, Swelling	14.3% 2/14 • Number of events 2 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	12.5% 2/16 • Number of events 3 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Gastrointestinal disorders Abdominal Pain	14.3% 2/14 • Number of events 3 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	6.2% 1/16 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Blood and lymphatic system disorders Bleeding	7.1% 1/14 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	0.00% 0/16 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Endocrine disorders Hypoglycemia	0.00% 0/14 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	6.2% 1/16 • Number of events 2 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Eye disorders Glaucoma	7.1% 1/14 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	0.00% 0/16 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Surgical and medical procedures Surgical resection	7.1% 1/14 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	6.2% 1/16 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Injury, poisoning and procedural complications Sprained ankle	7.1% 1/14 • Number of events 1 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up	0.00% 0/16 • 25 Weeks Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up

Additional Information

Joseph V. Boykin, Jr., MD

HCA Retreat Hospital, Institute of Plastic and Reconstructive Surgery

Phone: 804-353-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER