Trial Outcomes & Findings for Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers (NCT NCT02148302)

NCT ID: NCT02148302

Last Updated: 2020-04-29

Results Overview

Number of patients experiencing wound healing with epidermal grafting and standard of care vs. standard of care alone

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 123 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-04-29

Participant Flow

Participant milestones

Measure	Harvesting Device (CelluTome©) open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.	Control: SOC Alone The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
Overall Study STARTED	57	66
Overall Study COMPLETED	57	66
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers

Baseline characteristics by cohort

Measure	Harvesting Device (CelluTome©) n=57 Participants open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.	Control: SOC Alone n=66 Participants The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).	Total n=123 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	41 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	37 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants	64 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	66 participants n=7 Participants	118 participants n=5 Participants
Region of Enrollment Colombia	5 participants n=5 Participants	0 participants n=7 Participants	5 participants n=5 Participants
Area at Screening Visit	8.48 cm^2 STANDARD_DEVIATION 6.72 • n=5 Participants	7.59 cm^2 STANDARD_DEVIATION 6.81 • n=7 Participants	8.04 cm^2 STANDARD_DEVIATION 6.76 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Number of patients experiencing wound healing with epidermal grafting and standard of care vs. standard of care alone

Outcome measures

Measure	Harvesting Device (CelluTome©) n=57 Participants open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.	Control: SOC Alone n=66 Participants The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
Number of Patients With Healed Wounds	11 participants	16 participants

SECONDARY outcome

Timeframe: 4 weeks

Percentage of wound area change at week 4

Outcome measures

Measure	Harvesting Device (CelluTome©) n=57 Participants open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.	Control: SOC Alone n=66 Participants The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
Wound Area Change at Week 4	26.8 percentage of area change Standard Deviation 20.24	27.2 percentage of area change Standard Deviation 24.12

SECONDARY outcome

Timeframe: 12 weeks

Percentage of wound area change at Week 12

Outcome measures

Measure	Harvesting Device (CelluTome©) n=57 Participants open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.	Control: SOC Alone n=66 Participants The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
Wound Area Change at Week 12	41.7 percentage of area change Standard Deviation 21	47.4 percentage of area change Standard Deviation 21.5

SECONDARY outcome

Timeframe: 12 weeks

Incidence of adverse events with epidermal grafting versus standard of care.

Outcome measures

Measure	Harvesting Device (CelluTome©) n=57 Participants open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.	Control: SOC Alone n=66 Participants The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
Incidence of Adverse Event	28 percentage of participants	27 percentage of participants

Adverse Events

Harvesting Device (CelluTome©)

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Control: SOC Alone

Serious events: 6 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Harvesting Device (CelluTome©) n=57 participants at risk open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.	Control: SOC Alone n=66 participants at risk The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
Skin and subcutaneous tissue disorders Infection	8.8% 5/57 • Number of events 5 • Adverse event data was collected from enrollment to subject completion (12 weeks).	9.1% 6/66 • Number of events 6 • Adverse event data was collected from enrollment to subject completion (12 weeks).

Other adverse events

Measure	Harvesting Device (CelluTome©) n=57 participants at risk open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.	Control: SOC Alone n=66 participants at risk The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
General disorders Cold	26.3% 15/57 • Number of events 15 • Adverse event data was collected from enrollment to subject completion (12 weeks).	25.8% 17/66 • Number of events 17 • Adverse event data was collected from enrollment to subject completion (12 weeks).

Additional Information

Thomas E. Serena, MD

SerenaGroup

Phone: 617-945-5225

Email: serena@serenagroups.com

Results disclosure agreements

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

Restriction type: LTE60