Trial Outcomes & Findings for Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers (NCT 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

Target enrollment

24 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-05-22

Participant Flow

Participant milestones

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

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=99 Participants	61.1 years STANDARD_DEVIATION 12.29 • n=107 Participants	60.8 years STANDARD_DEVIATION 12.16 • n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	10 Participants n=107 Participants	18 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	10 Participants n=99 Participants	12 Participants n=107 Participants	22 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	12 participants n=99 Participants	12 participants n=107 Participants	24 participants n=206 Participants
BMI	32.5 kg/m^2 STANDARD_DEVIATION 5.24 • n=99 Participants	29.8 kg/m^2 STANDARD_DEVIATION 10.61 • n=107 Participants	31.2 kg/m^2 STANDARD_DEVIATION 7.93 • n=206 Participants
Smoker Current	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Smoker Former	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Smoker Never smoked	8 Participants n=99 Participants	6 Participants n=107 Participants	14 Participants n=206 Participants
HbA1c	7.5 Percentage STANDARD_DEVIATION 2.38 • n=99 Participants	7.6 Percentage STANDARD_DEVIATION 1.69 • n=107 Participants	7.6 Percentage STANDARD_DEVIATION 2.04 • n=206 Participants
Creatinine	1.08 mg/dL STANDARD_DEVIATION 0.24 • n=99 Participants	0.93 mg/dL STANDARD_DEVIATION 0.35 • n=107 Participants	1.01 mg/dL STANDARD_DEVIATION 0.30 • n=206 Participants
Years of DFUs	5.9 years STANDARD_DEVIATION 12.98 • n=99 Participants	4.9 years STANDARD_DEVIATION 16.45 • n=107 Participants	5.4 years STANDARD_DEVIATION 14.72 • n=206 Participants
Prior DFU count	3.8 Count of Ulcer STANDARD_DEVIATION 4.86 • n=99 Participants	3.9 Count of Ulcer STANDARD_DEVIATION 8.25 • n=107 Participants	3.9 Count of Ulcer STANDARD_DEVIATION 6.56 • n=206 Participants
Other concurrent DFUs (at screening) 0	9 Participants n=99 Participants	10 Participants n=107 Participants	19 Participants n=206 Participants
Other concurrent DFUs (at screening) 1	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Other concurrent DFUs (at screening) 2	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
History DFU recurrence	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Amputations, Minor 0	9 Participants n=99 Participants	6 Participants n=107 Participants	15 Participants n=206 Participants
Amputations, Minor 1	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Amputations, Minor 2	1 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants
Amputations, Minor 5	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Major amputations	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Foot deformities Charcot (stable)	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Foot deformities Plantar arthrodesis	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Foot deformities Ankle tarsal tunnel	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Foot deformities No deformities	10 Participants n=99 Participants	9 Participants n=107 Participants	19 Participants n=206 Participants
Wound area	2.3 cm2 STANDARD_DEVIATION 2.13 • n=99 Participants	2.4 cm2 STANDARD_DEVIATION 1.77 • n=107 Participants	2.35 cm2 STANDARD_DEVIATION 1.95 • n=206 Participants
Wound age	16.5 Weeks STANDARD_DEVIATION 13.63 • n=99 Participants	23.8 Weeks STANDARD_DEVIATION 12.4 • n=107 Participants	20.2 Weeks STANDARD_DEVIATION 13.02 • n=206 Participants
Vertical location Plantar	12 Participants n=99 Participants	11 Participants n=107 Participants	23 Participants n=206 Participants
Vertical location Dorsal	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
DFU position Medial	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
DFU position Lateral	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Anatomical location Toe	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Anatomical location Forefoot	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Anatomical location Midfoot	4 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants
Anatomical location Heel	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
History offloading type No offloading	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
History offloading type CAM boot	7 Participants n=99 Participants	5 Participants n=107 Participants	12 Participants n=206 Participants
History offloading type Surgical shoe	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Number of sharp debridements	3.5 Sharp debridements STANDARD_DEVIATION 1.45 • n=99 Participants	3.8 Sharp debridements STANDARD_DEVIATION 0.94 • n=107 Participants	3.7 Sharp debridements STANDARD_DEVIATION 1.2 • n=206 Participants
Chronic Kidney Disease (CKD)	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Hypertension	11 Participants n=99 Participants	6 Participants n=107 Participants	17 Participants n=206 Participants
Peripheral Arterial Disease/Peripheral Vascular Disease (PAD/PVD)	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Chronic Heart Failure (CHF)	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Leg edema	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Restricted mobility	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Venous disease	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Peripheral neuropathy	8 Participants n=99 Participants	12 Participants n=107 Participants	20 Participants n=206 Participants
Any psychiatric condition	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Comorbidity count	7.1 Comorbidities STANDARD_DEVIATION 4.06 • n=99 Participants	6.9 Comorbidities STANDARD_DEVIATION 4.06 • n=107 Participants	7 Comorbidities STANDARD_DEVIATION 4.06 • n=206 Participants

PRIMARY outcome

Timeframe: 4 weeks

Average Percentage of Wound Area Reduction from Treatment Visit 1 to Treatment Visit 4 measured manually with digital photography

Outcome measures

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 weeks

Population: Healed wounds only

Number of Participants with repeated applications of the Advanced Skin Substitute used to obtain wound closure

Outcome measures

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 1 Repeated Application	1 participants	0 participants
Number of Participants With Repeated Applications 2 Repeated Applications	1 participants	1 participants
Number of Participants With Repeated Applications 4 Repeated Applications	4 participants	2 participants

SECONDARY outcome

Timeframe: 5 weeks

The proportion of subjects that obtain complete closure over the 5-week treatment period

Outcome measures

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 weeks

The time to achieve complete wound closure of the target ulcer by the end of 5 weeks

Outcome measures

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 weeks

The 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

Dr. Subramanian Gunasekaran, PhD

Encoll Corp

Phone: +1 (510) 396-8581

Email: [email protected]

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