Clinical Trials

Inclusion Criteria:

- Chronic wound in the course of diabetic foot ulcers and/or lower extremity venous
ulcers with duration of at least 6 weeks and the wound surface not less than 2 sq. cm
and not greater than 15 sq. cm, without evidence of active infection of the wound at
the time of qualification to participate in the study
- Meets criteria for stalled chronic wound defined as less than 50% reduction in wound
size after 30 days of standard of care management.
- For chronic venous ulcers, ultrasound demonstrates venous reflux > 0.5 seconds
- Satisfactory blood glucose control - fasting not more than 110 mg%, HbA1c < 6.5%
- Satisfactory blood supply to the wound verified by the measurement of the oxygen level
of the foot tissue (TCPO2 > 30mmHg) in patients with neuropathic etiology of diabetic
foot syndrome
- In the case of the patients with the wounds of ischemic component, the condition for
qualification is a clinical improvement of the limb's blood supply as a result of the
revascularization procedure documented by ultrasound.
- Ankle-brachial index (ABI) ≥ 0.8

Exclusion Criteria:
- Acute wound with duration less than 6 weeks
- Evidence of active infection or on antibiotics
- Smoker
- For chronic venous ulcers, ultrasound demonstrates venous reflux < 0.5 seconds
- Unsatisfactory blood glucose control - fasting more than 110 mg%, HbA1c < 6.5%
- Poor blood supply to the wound verified by the measurement of the oxygen level of the
foot tissue (TCPO2 < 30mmHg) in patients with neuropathic etiology of diabetic foot
syndrome
- Ankle-brachial index (ABI) < 0.
- Pregnancy
- Known allergy to lidocaine

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/21/2024. Questions regarding updates should be directed to the study team contact.