NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing

Subjects will be taken to the operating room for the initial debridement procedure of the
wound. At the end of the procedure, subjects who continue to meet all inclusion and no
exclusion criteria will be randomized in a 1:1:1 ratio to be treated with either PRO, PRO
with simultaneous irrigation (PROI), or KCI Ulta NPWT. Prior to study initiation sealed
prenumbered randomization envelopes will be provided to the research staff and used to obtain
randomization assignment. Opening of the randomization envelop will occur intraoperatively at
the conclusion of the initial surgical debridement of the wound and conformation of all
eligibility requirements. Study staff will use the randomization number labels contained in
the envelop. The number will become the subject ID. The assignment will be subjects
randomized to PRO, PRO with simultaneous irrigation, or KCI Ulta NPWT.

The research staff will note treatment assignments on the intra operative randomization CRF
and instruct the investigator. Treatment therapy wound dressings will be applied in the
operating room or in the patient's room immediately after surgery per the investigators
discretion, according to the manufacturer's recommendations. In order to ensure consistent
study treatment, subjects will receive assigned treatment therapies within their study arm
after the initial and any subsequent surgical debridements until the wound is deemed ready
for closure or coverage by the Investigator. Subjects randomized to the PRO with simultaneous
irrigation Treatment arm are the only subjects that will receive irrigation therapy at any
time during the study treatment period. If irrigation therapy is discontinued, subjects in
the Treatment arm will transition to PRO NPWT without irrigation. Subjects randomized to the
PRO Control arm will receive NPWT only from the PRO therapy unit.

Inclusion Criteria:

- Presents with an existing chronic or traumatic wound, sub-acute or dehisced wound,
partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft as
diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)

- Wound presents with full thickness loss of epidermis and dermis

- The presentation of a wound that in the opinion of the investigators will require
surgical debridement, and the wound is expected to be a good candidate for NPWT and
eventual wound closure.

- ABI≥0.5 or toe pressures >30 PVR/mmHg

- Subject is willing and able to abstain from partaking in any other form of treatment
for his or her wound throughout the duration of his or her course of participation in
the clinical study, other than the study procedures described herein.

- 18 years of age or older

Exclusion Criteria:

- Does not present with an existing chronic or traumatic wound, sub-acute or dehisced
wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or
graft, or a definitive diagnosis cannot be made, as diagnosed by a qualified and
certified medical practitioner (M.D., D.O., or D.P.M)

- Wound does not present with full thickness loss of epidermis and dermis

- ABI<0.5 or toe pressures <30 PVR/mmHg

- Subject is not willing or is not able or it is not medically prudent for the subject
to abstain from partaking in any other form of treatment for his or her wound
throughout the duration of his or her course of participation in the clinical study,
other than the study procedures described.

- Subject is unwilling or unable to use the NPWT device at home

- Active Charcot arthropathy

- Collagen vascular disease

- Scleroderma

- Non-enteric and unexplored fistula

- Necrotic tissue with eschar present after debridement

- General skin disorder in the area of the wound such as psoriasis or penicilitis

- Malnutrition (defined as BMI <19)

- Hypercoagulable state based on documentation in their medical record

- Acute deep vein thrombosis

- Current active malignancy in the wound

- Current melanoma or history of melanoma at the wound

- Current active or history of invasive squamous cell carcinoma at the wound

- Sepsis (defined as positive blood culture with leukocytosis) and temperature >101.5 at
the time of screening

- Significant Hematologic disorders EXCLUDING anemia

- HIV

- Fever at screening > 101.5

- Deep X-ray therapy

- Untreated bone or soft tissue infection (osteomyelitis)

- Any concomitant illness(es) or medical condition(s) that in the opinion of the
investigator would render the subject not suited for study participation

- Subject is taking a regimen of any medication(s) in a significant enough dosage that
may affect chronic wound healing, including corticosteroid, chemotherapeutic and
non-steroidal anti-inflammatory (NSAID) medications

- Less than 18 years of age

- Developmental disability/significant psychological disorder that could impair the
subject's ability to provide informed consent, participate in the study protocol or
record study measures, including schizophrenia, bipolar disorder and psychiatric
hospitalization within the last 2 years.

- Females currently pregnant or planning pregnancy during the course of intended
participation in the study

- Active alcohol or substance abuse in the opinion of the investigator that could impair
the subjects ability to provide informed consent, participate in the study protocol or
record study measures.