Trial Outcomes & Findings for LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers (NCT NCT01454401)

NCT ID: NCT01454401

Last Updated: 2023-04-24

Results Overview

Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 20 weeks
• Results posted on: 2023-04-24

Participant Flow

Recruitment period: 18-01-2011 (FPI) to 14-01-2013 (LPO) Non -ischemic Wagner grade 1 or 2 diabetic foot ulcer (DFU) with a duration of more than 6 weeks and a maximal area of 10 cm2 Patients with > 40% ulcer area change during a two-week run-in period were excluded.

16 patients were excluded during run-in period: >40% ulcer area reduction n=5 HbA1c > 12% n=3 haemoglobin < 9,5% g/dl, n=1 ulcer area > 10 cm2, n=1 amputation n=1 withdrawn consent, n=2 Osteomyelitis n=1 wrongly included n=2

Participant milestones

Measure	LeucoPatch Treatment of Diabetic Foot Ulcers Weekly LeucoPatch treatment of diabetic foot ulcers
Overall Study STARTED	44
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	LeucoPatch Treatment of Diabetic Foot Ulcers Weekly LeucoPatch treatment of diabetic foot ulcers
Overall Study Death	1
Overall Study hospitalised	1
Overall Study osteomyelitis	2
Overall Study non-adherence	1

Baseline Characteristics

LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Baseline characteristics by cohort

Measure	LeucoPatch Treatment of Diabetic Foot Ulcers n=44 Participants Weekly treatment LeucoPatch device: weekly treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age, Continuous All	63 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Diabetes Type 1	8 participants n=5 Participants
Diabetes Type 2	36 participants n=5 Participants
Body Mass Index (kg/m2)	29.7 kg/m^2 n=5 Participants
Presence of neuropathy Yes	42 participants n=5 Participants
Presence of neuropathy No	2 participants n=5 Participants
Ulcer duration (weeks)	35 weeks n=5 Participants
Ulcer area	1.1 cm^2 n=5 Participants
Wagner classification Wagner grade 1	19 participants n=5 Participants
Wagner classification Wagner grade 2	25 participants n=5 Participants
Biochemistry Haemoglobin	126 g/l n=5 Participants
Biochemistry Platelets	262 10^9 cells/l n=5 Participants
Biochemistry Leucocytes	8.0 10^9 cells/l n=5 Participants
HbA1c	65 mmol/mol n=5 Participants

PRIMARY outcome

Timeframe: 20 weeks

Population: Number of the patients achieved complete epithelialisation at 20 weeks in the ITT population and in the PP population

Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.

Outcome measures

Measure	LeucoPatch n=44 Participants LeucoPatch: weekly treatment
Ulcer Healing Within 20 Weeks Healed ITT; n=44	23 participants
Ulcer Healing Within 20 Weeks Healed PP; n=39	23 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Complete epithelialisation was achieved in 15 patients (34%) in ITT population and 38% in the PP population

Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population

Outcome measures

Measure	LeucoPatch n=44 Participants LeucoPatch: weekly treatment
Ulcer Healing Within 12 Weeks. Healed ITT; n=44	15 participants
Ulcer Healing Within 12 Weeks. Healed PP; n=39	15 participants

Adverse Events

All Patients Consenting to be Enrolled in the Study.

Serious events: 8 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients Consenting to be Enrolled in the Study. n=60 participants at risk 60 patients were included for a 2 week run-in period. If ulcer area decreased more than 40% during that time the ulcer were deemed "healing" and NOT included for treatment. 16 patients were excluded during the run-in period - 44 were treated. For safety analysis all patients were included
Infections and infestations SAE not related to Leucopatch treatment	3.3% 2/60 • Number of events 2
Cardiac disorders SAE not related to Leucopatch treatment	3.3% 2/60 • Number of events 2
Vascular disorders SAE not related to Leucopatch treatment	1.7% 1/60 • Number of events 1
Respiratory, thoracic and mediastinal disorders SAE not related to Leucopatch treatment	3.3% 2/60 • Number of events 2
Blood and lymphatic system disorders SAE not related to Leucopatch treatment	1.7% 1/60 • Number of events 3
Surgical and medical procedures SAE not related to Leucopatch treatment	1.7% 1/60 • Number of events 1

Other adverse events

Measure	All Patients Consenting to be Enrolled in the Study. n=60 participants at risk 60 patients were included for a 2 week run-in period. If ulcer area decreased more than 40% during that time the ulcer were deemed "healing" and NOT included for treatment. 16 patients were excluded during the run-in period - 44 were treated. For safety analysis all patients were included
Infections and infestations AE	1.7% 1/60 • Number of events 1
Skin and subcutaneous tissue disorders AE	1.7% 1/60 • Number of events 1
Investigations AE	3.3% 2/60
Surgical and medical procedures AE	1.7% 1/60 • Number of events 1
Blood and lymphatic system disorders AE	3.3% 2/60 • Number of events 2
Gastrointestinal disorders AE	1.7% 1/60 • Number of events 1
Renal and urinary disorders AE	1.7% 1/60 • Number of events 1
Metabolism and nutrition disorders AE	1.7% 1/60 • Number of events 1
General disorders AE	3.3% 2/60 • Number of events 2
Injury, poisoning and procedural complications AE	1.7% 1/60 • Number of events 1

Additional Information

MD, PhD Senior Consultant Magnus Löndahl

Reapplix Blokken 45 3460 Birkerød Denmark

Email: magnus.londahl@med.lu.se

Results disclosure agreements

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