A prospective single centre, open label, pilot study to evaluate the safety of ICXP007 plus standard of care, for the treatment of lower extremity chronic, neuropathic diabetic foot ulcers - DFU I

Phase 1

Active, not recruiting

• Conditions: Diabetic foot ulcers

• Registration Number: EUCTR2006-000692-15-GB
• Lead Sponsor: Intercytex

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Signed IRB approved informed consent obtained prior to the first study intervention.
2. Age equal to or greater than 40 and less than 85 years old at the time the informed consent is signed.
3. Subjects will have a diabetic ulcer on the lower extremity, with the ulcer having all of the following characteristics:
a. Full-thickness plantar ulcers.
b. Non-infected as determined by clinical assessment.
c. Neuropathic as determined by neuro disability score 6 or more.
d. Area greater than or equal to 1.0 cm squared and less than or equal to 20.0 cm squared post debridement.
e. Has been present for at least 4 weeks under observation at the time of enrollment.
f. Extends through the dermis but without tendon, muslce, capsule or bone exposure.

4. Subjects will have either insulin-dependent or non-insulin-dependent diabetes mellitus with a HbA1c value in the range of 6% to 12%.
5. The ulcer bed at the time of enrollment must be free of all necrotic and infected soft and bony tissue as determined by clinical examination (no evidence of probing to bone).
6. Ankle-brachial systolic pressure index greater than 0.7 and palpable foot pulses.

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. Malignant or connective tissue disease.
2. Individuals who have received short course corticosteriods within 30 days, or oral or parenteral chronic immunosupressants within 90 days prior to treatment.
3. Individuals with a known hypersensitivity to Aprotinin or any other constituents of Tisseel VH S/D TM i.e. Fibrinogen (human), thrombin (human) and calcium chloride, bovine and porcine products.
4. Individuals who have a target ulcer which shows signs of clinical infection as determined by clinical examination.
5. Active febrile illness (fever greater than or equal to 38.0 degrees centigrade)
6. Renal or liver impairment as indicated by serum creatinine levels and liver function tests three or more times higher than normal values.
7. Subject has an active Charcot as determined by clinical examination (new local pain, evidence of swelling and warmth).
8. Subjects who refuse or who are unable to participate in all screening procedures, or to comply with the requirements of the study.
9. Use of other investigational products at the time of enrolment or during the study.
10. The use of any topical treatments, other than SOC, in or on the surface of the target ulcer at the time of enrolment.
11. Subjects who have been enrolled in any investigational clinical trial within 30 days of the screening visit.
12. Recent or current history of alcohol or drug abuse.
13. Females who are pregnant, lactating, or who have not reached menopause and are not abstinent or practising an acceptable means of birth control as determined by the investigator for the duration of the study.
14. Subjects who have critical limb ischemia.

Study & Design

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