VELGRAFT for chronic diabetic foot ulcers with granulation tissue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, randomized, double-blind, active-controlled study enrolls up to 24 adults with chronic diabetic foot ulcers that have attained granulation tissue. The trial has two parts: an initial dose-escalation phase to identify the maximum tolerated number of VELGRAFT applications, followed by a randomized comparison of VELGRAFT versus a standard moist dressing using the dose determined in Part A. Treatments are applied weekly during a 12-week treatment period, with a final follow-up at 24 weeks and overall participation up to about 183 days. Safety is the primary focus, with secondary endpoints measuring wound-healing efficacy relative to standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Patient has current diagnosis of type 1 or type 2 diabetes mellitus
3. Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
4. Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1
5. Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

   i. Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30mmHg, OR ii. ABIs (Ankle brachial index) with results of ≥0.7 and ≤1.2, OR iii. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
6. For female patients of childbearing potential, commitment to using a medically accepted means of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout study period and tests negative on a pregnancy test
7. Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner's scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment
8. Able and willing to wear an off-loading device or orthopedic shoe

Exclusion Criteria:

1. Gangrene is present on any part of the affected foot
2. Ulcer is of non-diabetic pathophysiology
3. Patient's ulcer is over a Charcot deformity
4. Ulcer total surface area \> 20 cm2
5. Osteomyelitis, cellulitis, or other evidence of infection
6. Patient is currently being treated, or received treatment within one month prior, with chemotherapeutic agents, immunosuppressive agents, radiation therapy, or corticosteroids
7. Patient has AIDS, HIV, or cardiac (ejection fraction less than 50% on 2D-ECHO; t-wave inversion on ECG), endocrine (hypothyroidism), disease, or present symptoms/complaints suggestive of gastrointestinal, neurological, or immune disease, that in the opinion of the Investigator, would make the patient an inappropriate candidate for this wound healing study.
8. Patient with any of the below physiological parameters:

   i. BP systolic \>140 or \<90 mmHg or diastolic \>90 or \<60mmHg ii. Pulse \<60 or \>100bpm iii. Respiratory Rate \<9 and \>20 bpm iv. Pulse Oximetry \<94% in room air v. Temp \>100.4 degrees Fahrenheit vi. ALT and AST \>2 times the upper limit of normal (ULN) vii. Abnormal bilirubin unless subject has Gilbert's viii. eGFR \<60 mL/min/1.73 m2 by CKD-EPI ix. Platelet Count \<100,000 x. HbA1c: ≥8.5% xi. Hemoglobin: ≤10g/dL
9. Patients presenting with an ulcer probing to the bone (UT Grade IIIA-D).
10. Patients with Wagner Grades 2-6 ulcers.
11. Patient has had a previous lower extremity amputation.
12. Received allograft, autograft, xenograft, or cellular therapy within 30 days of screening
13. Female patients who are nursing, pregnant, or planning on becoming pregnant during the study period.
14. Patient is unwilling or unable to comply with the postoperative visits necessary for data collection.
15. Patients with known hypersensitivity to the components of the product or shipping medium.

Where it's running

• Advanced Foot Care
  Phoenix, Arizona, United States Recruiting

Study contacts

• Study coordinator: Dr Deepa Arora
• Email: info@clinexel.com
• Phone: +917738804988

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.