A Phase III, Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of aCureXCell(TM) as an Adjunct to Good Wound Care Measures in Treating Lower Extremity Chronic Ulcers in Adults with Diabetes Mellitus

Study ID
STU 052012-015

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • UT Southwestern University Hospital—St. Paul
  • Parkland Health & Hospital System

Contact
Cecilia Lara
214-645-8923
cecilia.lara@utsouthwestern.edu

Principal Investigator
Lawrence Lavery

Summary

This is a multinational, multicenter, randomized, double-blind, parallelgroup,
sham-controlled study designed to evaluate the tolerability, safety
and efficacy of aCureXcell[TM] as adjunct to good ulcer care (GuC) in
treating ulcers on or below the malleoli in adults with diabetes mellitus.
The study is comprised of two main phases: a core double-blind treatment phase
and a follow-up phase.
Primary efficacy endpoint
The primary efficacy endpoint is the proportion of patients with complete healing/closure of
their target ulcer at any time during the 16-week double-blind core treatment period and
sustained complete closure for 4 additional weeks of follow-up.
Safety endpoints
The safety endpoints are the following:
Frequency of aes
intensity of aes
Frequency of related aes
Frequency of Saes
infections (as declared by the investigator)
Systemic immune reactions.

Participant Eligibility

Inclusion Criteria:
To be eligible for the study, patients must fulfill all of the following
criteria at Screening and Baseline, as applicable:
1. Males or females at least 18 years of age (inclusive) with
diabetes type 1 or type 2;
2. Patients must sign an informed consent that complies with
International Conference on Harmonization (ICH) guidelines and
applicable local regulatory requirements (e.g. US 21 CFR 50) prior to
undergoing any study-related procedures;
3. Patients with HbA1c <= 12%;
4. Patients with at least one lower extremity (on or below the malleoli)
full-thickness ulcer (penetrating skin), which has been
unresponsive to good ulcer care and open for at least 4 weeks;
5. Target ulcers with an area between >= 1 cm2 and <= 20 cm2 (after sharp debridement of non-viable, hyperkeratotic and fibrotic tissue as to the extent
possible);
6. Total area of all ulcers (target and non-target) <=40 cm2;
7. Women of childbearing potential must have a negative serum
pregnancy test and will use at least one reliable form of birth
control (e.g. a stable dose of an oral contraceptive for at least 3
months prior to screening or an intrauterine device or a combination
of condom and spermicide) throughout the study. Women must not be breastfeeding.
8. Patients must agree to comply with dressing regimen
and off-loading according to protocol requirements;
9. Ankle Brachial Index >= 0.65;
10. Absence of osteomyelitis as determined by plain MRI, tagged WBC scan (for those who cannot undergo MRI) or bone biopsy, if any of the following are present:

* There is a clinical suspicion of osteomyelitis;

* Ulcer considered for treatment is located at the site of a past amputation,

* History of acute osteomyelitis in the past 90 days or history of recurrent osteomyelitis; or

* A positive
* probe to bone test
* .

11. Life expectancy >= 1 year from recruitment to study as determined by
the investigator.