A randomized, double-blind, multi-centre, placebo-controlled, parallel-group study to examine the efficacy and safety of low dose Epoetin beta on wound healing in diabetes patients with foot ulcer

• Conditions: wound healing in diabetes patients with foot ulcer; MedDRA version: 8.1Level: LLTClassification code 10048037Term: Wound healing disturbance of

• Registration Number: EUCTR2006-002758-31-BG
• Lead Sponsor: EPOPLUS GmbH & Co.KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Diabetic patients with foot ulcer below the ankle will be randomised into 2 treatment
arms:
a. diagnosis of diabetes and neuropathic ulcer Wagner I or II (as indicated by a
neuropathy deficit score 6-10, palpaple foot pulses and an ABI-index =1.0)
or
b. diagnosis of diabetes and ulcer Wagner I/II or wounds after amputations in
patients with peripheral arterial occlusive disease (as indicated by the
presence of one of the following: missing foot pulses and an ABI-index =0.8,
or a history of insufficient vascularisation on the target leg*).
*Angiographically documented peripheral arterial occlusive disease and no
surgical or endovascular treatment option.
2. Ulcer size over 0.5 cm2.
3. Male or female aged = 18 years.
4. Signed written informed consent to participate in this trial.
5. Female of childbearing potential with a negative pregnancy test, and agrees to use
an acceptable contraceptive method (hormonal or IUD) throughout the study.
6. HbA1c = 10% or, if > 10% then stable blood glucose level within the last 4 weeks,
i.e. fasting blood glucose value < 160 mg/dl.
7. At least one foot ulcer, the size of which can be documented using a transparent
foil.
8. Weight between 50 kg and 160 kg.
9. Patients without significant healing after a 4 week Run-In period can be randomized
into a treatment arm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or nursing women.
2. Myeloplastic or proliferative disease.
3. Known infection with hepatitis B or hepatitis C or HIV.
4. Therapy with rHuEPO or analogic medicine within the last 6 months.
5. Bleeding episodes which affect the Hb value or known gastro-intestinale bleedings
within the last 3 months.
6. Known or suspected intolerance to erythropoetic factors, e.g. NeoRecormon®,
Aranesp®, Erypo®.
7. Treatment with systemic chemotherapy or radiotherapy or immunosuppressives or
systemic corticosteroids within the last 6 months prior to treatment start.
8. Previous therapy with growth factors, e.g. GM-CSF, VEGF in the last 6 months.
9. Intake of any medication which interacts with epoetin beta (e.g. Cyclosporin).
10. Uncontrolled systolic blood pressure > 160 mmHg (supine) and/or diastolic blood
pressure > 100 mmHg.
11. Deep vein thrombosis or pulmonary embolism within the previous 6 months
12. Stroke, instable angina pectoris, STEMI or NSTEMI within the last 3 months.
13. Psychiatric disease or chronic cerebellar fits.
14. Scheduled for vascular surgery or any other intervention surgery within 4 weeks to trial
start or during the trial or patients, who could benefit from vascular surgery or other
invasive intervention.
15. Hereditary or acquired thrombophilia, recurrent thrombotic events (> 2) or thrombosis
of uncertain aetiology.
16. Atrial septum defect.
17. Transient ischaemic attack (TIA) within the last 3 months.
18. Prolonged reversible ischemic neurological deficit (PRIND) within the last 3 months.
19. Artificial heart valves (mechanical or biological)
20. Alcohol or drug abuse.
21. Non-compliance and/or participation in a clinical trial within the last 3 months prior to
screening.
22. Patients in dialysis program or chronical renal failure Grad IV.
23. Patients with known bleedings, MCV below normal ranges, and iron deficiency anemia
24. Hemoglobin, hematocrit and platelet count above the upper limit of normal according
to the local laboratory
25. Antibiotic treatment of the target wound at time of randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effects of a systemic treatment with erythropoietin on wound closure in<br>patients with diabetes and diabetic foot syndrome;Secondary Objective: The secondary objectives of the study are:<br>a) To evaluate the wound healing, i.e. area of the target (biggest) ulcer, from baseline to<br>week 13 (percentage and absolute change).<br>b) To evaluate the microcirculation (only at selected study sites).<br>c) To describe the one-year survival status/amputation rate/recurrence of target ulcer.<br>d) To evaluate the wound healing, i.e. depth of the target ulcer from baseline to week 13.<br>e) To evaluate the time to wound closure.<br>f) To evaluate the reduction of pain.<br>g) Safety and tolerability.;Primary end point(s): Primary endpoint is complete wound closure of the target ulcer.