Diabetic Foot Ulcers
Conditions
Brief summary
The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.
Detailed description
Summary: Treatment Study The goal of the LeucoPatch ™ study is to investigate the effect of LeucoPatch ™ in diabetic foot ulcer. LeucoPatch ™ is a biologically active dressings which are made solely by the patient's own blood (autologous). It is produced in the CE (European Conformity) marked LeucoPatch™ Device and contains no additives. In this treatment study up to 75 typical diabetic patients with foot ulcers are included. These wounds are typically chronic and lead to reduced quality of life and ability to work, and extensive treatment costs. Furthermore, these wounds often lead to amputations.The study is a multicenter study in which up to 10 wound clinics are expected to be involved. The primary endpoint is time to complete healing, the secondary endpoint is change in wound size.
Interventions
DEVICELeucoPatch treatment
weekly
Sponsors
Reapplix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Type I or Type II Diabetes * Age of wounds \> 6 weeks * Wound area \<10 cm2 * Wounds: Texas degree ≤ type IIa * Perfusion status: toe pressure\> 30 mmHg, or transcutaneous oxygen measurement (TcPO2)\> 30 mmHg on the foot (measured within the last 3 months) or palpable foot pulse (equivalent to\> 60 mmHg) * Diabetes control: HbA1c \<12% * Adequate off-loading (Walker, therapy sandals etc.) * The patient can adhere to the treatment protocol and is expected to conclude the study * Written informed consent
Exclusion criteria
* Non-Danish or Swedish speaking * Dementia * Pregnant or nursing women * The patient cannot tolerate blood donation * Hemoglobin : \< 6,5 mmol/l or 105 g/l * Haemophilia, Sickle cell anemia, severe thrombocytopenia, and leukemia or blood dyscrasias. * Patient on dialysis * Clinical signs of infection - including osteomyelitis (probe to bone). * Necrosis of the wound * 40% change (+/-) in ulcer area in a 2-week run-in period with optimal therapy. * Blood vessel reconstruction within the last 4 weeks. * Participation in other clinical wound healing studies in the last 30 days. * Failure to comply with study protocol in the 2-week run-in period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Healing Within 20 Weeks | 20 weeks | Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Healing Within 12 Weeks. | 12 weeks | Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population |
Countries
Denmark, Sweden
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| LeucoPatch Treatment of Diabetic Foot Ulcers Weekly treatment
LeucoPatch device: weekly treatment | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | hospitalised | 1 |
| Overall Study | non-adherence | 1 |
| Overall Study | osteomyelitis | 2 |
Baseline characteristics
| Characteristic | LeucoPatch Treatment of Diabetic Foot Ulcers |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous All | 63 years |
| Biochemistry Leucocytes | 8.0 10^9 cells/l |
| Biochemistry Platelets | 262 10^9 cells/l |
| Biochemistry Haemoglobin | 126 g/l |
| Body Mass Index (kg/m2) | 29.7 kg/m^2 |
| Diabetes Type 1 | 8 participants |
| Diabetes Type 2 | 36 participants |
| HbA1c | 8.1 % |
| Presence of neuropathy No | 2 participants |
| Presence of neuropathy Yes | 42 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 35 Participants |
| Ulcer area | 1.1 cm^2 |
| Ulcer duration (weeks) | 35 weeks |
| Wagner classification Wagner grade 1 | 19 participants |
| Wagner classification Wagner grade 2 | 25 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 60 |
| serious Total, serious adverse events | 8 / 60 |
Outcome results
Primary
Ulcer Healing Within 20 Weeks
Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.
Time frame: 20 weeks
Population: Number of the patients achieved complete epithelialisation at 20 weeks in the ITT population and in the PP population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LeucoPatch | Ulcer Healing Within 20 Weeks | Healed ITT; n=44 | 23 participants |
| LeucoPatch | Ulcer Healing Within 20 Weeks | Healed PP; n=39 | 23 participants |
Secondary
Ulcer Healing Within 12 Weeks.
Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population
Time frame: 12 weeks
Population: Complete epithelialisation was achieved in 15 patients (34%) in ITT population and 38% in the PP population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LeucoPatch | Ulcer Healing Within 12 Weeks. | Healed ITT; n=44 | 15 participants |
| LeucoPatch | Ulcer Healing Within 12 Weeks. | Healed PP; n=39 | 15 participants |