A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs

Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:

1. Subject is 18 years of age or older.

2. Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral/injectable medications to control blood glucose levels

3. Glycosylated hemoglobin (HbA1c) level is \<12%

Note: Prior documented HbA1c within 12 weeks of Screening is acceptable.

4. Duration of ulcer is ≥ 4 weeks but ≤ 1 year, unresponsive to SOC

5. Ulcer area is ≥ 1.5cm2 and ≤ 20cm2 and with a clean, granulating base with minimal adherent slough at the Baseline Visit

6. Ulcer location is at or below the ankle (malleolus)

7. Subject is amenable to use of off-loading, as needed for plantar ulcer

8. Ulcer extends through the full thickness of the skin but not down to muscle, tendon, or bone

9. Subject is at least 12 weeks post lower extremity revascularization procedure, if one has been performed.

10. Subject is in general good health, with no clinically significant medical conditions or abnormalities that, in the opinion of the Investigator, would interfere with study participation, the assessment of study endpoints, or pose additional risk to the subject.

11. Adequate circulation to the affected lower extremities as demonstrated by one of the following within 12 weeks of screening:

1. Dorsum transcutaneous oxygen measurement (TCOM) ≥ 30 mmHg,

2. Skin perfusion pressure (SPP) measurement ≥ 30 mmHg,

3. Ankle-Brachial Index (ABI) ≥0.7 and ≤1.2, OR

4. Toe-Brachial Index (TBI) ≥ 0.6

12. Subject is willing to use an acceptable method of contraception throughout the duration of the trial, if of childbearing potential.

Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, patch, injectable, depot or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide or sponge), or female subject/partner's use of an implantable device (implantable rod or intrauterine device).

Female subject/partners of non-childbearing potential are defined as surgically sterile (e.g., bilateral tubal ligation, hysterectomy) or two years postmenopausal at time of screening.

All male subjects (excluding men who have been sterilized) with female partners of child-bearing potential must agree to consistently and correctly use a condom for the duration of the study. In addition, subjects may not donate sperm for the same time period.

13. Subject is able to read, understand and sign the informed consent form (ICF).

14. Subject is available and willing to complete all study assessments and can comply with standard of care (debridement, dressing changes etc.) as applicable.

A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs

What this study is about

A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs

What this study is about