To compare HP828-101 to standard of care for the management of partial or full thickness wounds
The primary objective is to compare HP828-101 to standard of care for the management of partial or full thickness wounds, evaluated using the Bates Jensen Wound Assessment Tool (BWAT). The secondary objectives are comparison of the proportion of subjects with wound closure by day 22, comparison of pain assessed using a visual analog scale (VAS), and evaluation of moist wound environment as per the BWAT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
88
Topical test article applied once daily
Hydrogel for DFU and Hydrocolloid for PU (3M Tegaderm Hydrogel for DFU; ConvaTec DuoDERM Hydroactive Gel for PU); Topical test articles applied once daily
Trovare Clinical Research
Bakersfield, California, United States
Absolute Foot Care
Chula Vista, California, United States
Roy Kroeker
Fresno, California, United States
Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.
Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Time frame: 22 - 29 days
Number of Participants With Wound Closure by Day 22.
Time frame: 22 days
Pain Assessed by a 100-mm VAS Scale.
100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain)
Time frame: At every visit: Day 8, Day 15, Day 22, Day 29
Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)
Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound exudate type and amount) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Time frame: At every visit: Day 8, Day 15, Day 22, Day 29
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Innovative Medical Technologies
Los Angeles, California, United States
San Diego Research Center
San Diego, California, United States
Foot and Ankle Associates of Florida
Altamonte Springs, Florida, United States
Weil Foot and Ankle Institute
Des Plaines, Illinois, United States
Prigoff-Bowers LLP
Dallas, Texas, United States
Richard Galperin, DPM
Dallas, Texas, United States
Robert Wunderlich, DPM
San Antonio, Texas, United States
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