Trial Outcomes & Findings for Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers (NCT NCT06557122)
NCT ID: NCT06557122
Last Updated: 2025-05-22
Results Overview
Average Percentage of Wound Area Reduction from Treatment Visit 1 to Treatment Visit 4 measured manually with digital photography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-05-22
Participant Flow
Participant milestones
| Measure |
SOC and Advanced Bioengineered Skin Substitute
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll®
|
SOC and Active Comparator
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix®
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
SOC and Advanced Bioengineered Skin Substitute
n=12 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll®
|
SOC and Active Comparator
n=12 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix®
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 12.03 • n=93 Participants
|
61.1 years
STANDARD_DEVIATION 12.29 • n=4 Participants
|
60.8 years
STANDARD_DEVIATION 12.16 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
BMI
|
32.5 kg/m^2
STANDARD_DEVIATION 5.24 • n=93 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 10.61 • n=4 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 7.93 • n=27 Participants
|
|
Smoker
Current
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Smoker
Former
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Smoker
Never smoked
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
HbA1c
|
7.5 Percentage
STANDARD_DEVIATION 2.38 • n=93 Participants
|
7.6 Percentage
STANDARD_DEVIATION 1.69 • n=4 Participants
|
7.6 Percentage
STANDARD_DEVIATION 2.04 • n=27 Participants
|
|
Creatinine
|
1.08 mg/dL
STANDARD_DEVIATION 0.24 • n=93 Participants
|
0.93 mg/dL
STANDARD_DEVIATION 0.35 • n=4 Participants
|
1.01 mg/dL
STANDARD_DEVIATION 0.30 • n=27 Participants
|
|
Years of DFUs
|
5.9 years
STANDARD_DEVIATION 12.98 • n=93 Participants
|
4.9 years
STANDARD_DEVIATION 16.45 • n=4 Participants
|
5.4 years
STANDARD_DEVIATION 14.72 • n=27 Participants
|
|
Prior DFU count
|
3.8 Count of Ulcer
STANDARD_DEVIATION 4.86 • n=93 Participants
|
3.9 Count of Ulcer
STANDARD_DEVIATION 8.25 • n=4 Participants
|
3.9 Count of Ulcer
STANDARD_DEVIATION 6.56 • n=27 Participants
|
|
Other concurrent DFUs (at screening)
0
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Other concurrent DFUs (at screening)
1
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Other concurrent DFUs (at screening)
2
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
History DFU recurrence
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Amputations, Minor
0
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Amputations, Minor
1
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Amputations, Minor
2
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Amputations, Minor
5
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Major amputations
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Foot deformities
Charcot (stable)
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Foot deformities
Plantar arthrodesis
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Foot deformities
Ankle tarsal tunnel
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Foot deformities
No deformities
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Wound area
|
2.3 cm2
STANDARD_DEVIATION 2.13 • n=93 Participants
|
2.4 cm2
STANDARD_DEVIATION 1.77 • n=4 Participants
|
2.35 cm2
STANDARD_DEVIATION 1.95 • n=27 Participants
|
|
Wound age
|
16.5 Weeks
STANDARD_DEVIATION 13.63 • n=93 Participants
|
23.8 Weeks
STANDARD_DEVIATION 12.4 • n=4 Participants
|
20.2 Weeks
STANDARD_DEVIATION 13.02 • n=27 Participants
|
|
Vertical location
Plantar
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Vertical location
Dorsal
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
DFU position
Medial
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
DFU position
Lateral
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Anatomical location
Toe
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Anatomical location
Forefoot
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Anatomical location
Midfoot
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Anatomical location
Heel
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
History offloading type
No offloading
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
History offloading type
CAM boot
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
History offloading type
Surgical shoe
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Number of sharp debridements
|
3.5 Sharp debridements
STANDARD_DEVIATION 1.45 • n=93 Participants
|
3.8 Sharp debridements
STANDARD_DEVIATION 0.94 • n=4 Participants
|
3.7 Sharp debridements
STANDARD_DEVIATION 1.2 • n=27 Participants
|
|
Chronic Kidney Disease (CKD)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Hypertension
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Peripheral Arterial Disease/Peripheral Vascular Disease (PAD/PVD)
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Chronic Heart Failure (CHF)
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Leg edema
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Restricted mobility
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Venous disease
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Peripheral neuropathy
|
8 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Any psychiatric condition
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Comorbidity count
|
7.1 Comorbidities
STANDARD_DEVIATION 4.06 • n=93 Participants
|
6.9 Comorbidities
STANDARD_DEVIATION 4.06 • n=4 Participants
|
7 Comorbidities
STANDARD_DEVIATION 4.06 • n=27 Participants
|
PRIMARY outcome
Timeframe: 4 weeksAverage Percentage of Wound Area Reduction from Treatment Visit 1 to Treatment Visit 4 measured manually with digital photography
Outcome measures
| Measure |
SOC and Advanced Bioengineered Skin Substitute
n=12 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll®
|
SOC and Active Comparator
n=12 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix®
|
|---|---|---|
|
Percentage of Wound Area Reduction
|
83.9 Percentage of Wound Area Reduction
Standard Deviation 24.93
|
71.3 Percentage of Wound Area Reduction
Standard Deviation 36.80
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Healed wounds only
Number of Participants with repeated applications of the Advanced Skin Substitute used to obtain wound closure
Outcome measures
| Measure |
SOC and Advanced Bioengineered Skin Substitute
n=6 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll®
|
SOC and Active Comparator
n=3 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix®
|
|---|---|---|
|
Number of Participants With Repeated Applications
4 Repeated Applications
|
4 participants
|
2 participants
|
|
Number of Participants With Repeated Applications
1 Repeated Application
|
1 participants
|
0 participants
|
|
Number of Participants With Repeated Applications
2 Repeated Applications
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 5 weeksThe proportion of subjects that obtain complete closure over the 5-week treatment period
Outcome measures
| Measure |
SOC and Advanced Bioengineered Skin Substitute
n=12 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll®
|
SOC and Active Comparator
n=12 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix®
|
|---|---|---|
|
Proportion of Complete Closure
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 weeksThe time to achieve complete wound closure of the target ulcer by the end of 5 weeks
Outcome measures
| Measure |
SOC and Advanced Bioengineered Skin Substitute
n=12 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll®
|
SOC and Active Comparator
n=12 Participants
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix®
|
|---|---|---|
|
Time to Achieve Complete Wound Closure
|
28.3 Days
Interval 27.8 to 28.9
|
26.8 Days
Interval 24.3 to 29.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 weeksThe number and type of Treatment Emergent Adverse Events
Outcome measures
Outcome data not reported
Adverse Events
SOC and Advanced Bioengineered Skin Substitute
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SOC and Active Comparator
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
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators shall not independently publish, publicly disclose, present or discuss any results or information pertaining to study conducted under the mutual agreement until such a multi-center publication is released under Sponsor's direction.
- Publication restrictions are in place
Restriction type: OTHER