Trials Today

Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

In order to be eligible to participate in this study, subjects must meet all of the
following criteria:

1. Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony
debridement and flap coverage/primary closure.

2. Operative candidate for flap surgery or primary closure.

3. Presence of focal osteomyelitis as suggested by imaging to show extent of infection.
Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.

4. Adults ≥ 18 years in age at the time of treatment.

5. Psychosocially, mentally, and physically able to fully comply with this protocol,
including adhering to scheduled visits, treatment plan, completing forms, and other
study procedures.

6. Ability of the subject or legal authorized representative to provide voluntary,
signed and dated informed consent prior to any study-related procedures.

Subjects who meet any of the following criteria will be excluded from participating in
this study:

1. Reasons contributing to pressure ulcer cannot be addressed.

2. Severe immunological compromised patients as determined by the clinician.

3. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to
adequate margins for debridement.

4. Patients presenting with head pressure ulcers.

5. Current or recent history (within last 2 years) of active substance abuse (e.g.,
recreational drugs, narcotics, or alcohol) that in the judgement of the
investigator, may compromise the participant's safety/recovery or ability to follow
the trial procedures.

6. Current smoker.

7. Diabetic patient with Hba1C level above 9.

8. Allergy to any component of the investigational product, such as calcium sulfate,
glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).

9. Concurrent involvement in a study of another investigational product.

10. Pregnant or planning to become pregnant during study period.

11. Flexion contractures where patient cannot passively get full extension.

12. Uncontrolled muscle spasms.

13. Unable to comply with bedrest restriction or offloading requirements

14. Unable to provide consent.

15. Fecal or urinary incontinence with contamination of the wound.

16. Lower extremity pressure ulcer location that is vascularly compromised as defined by
an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤
40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg *

17. Investigator considers the participant to be clinically malnourished.

18. Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk
for developing hypercalcemia (i.e., Hyperparathyroidism).

19. Investigator believes trial participation may compromise safety of the participant
or trial results.

- Patients presenting with lower extremity pressure ulcers that are vascularly
compromised can be rescreened followed successful revascularization