Nutritional Regulation of Wound Inflammation: Part III

There are a total of 3 study visits over the course of the 12 weeks of the study that will
include procedures such as collection of their wound dressing, imaging, blood draw, and
receiving the supplement (if in supplementation group). These visits will occur at weeks 0
(consent signed and first distribution of supplements), 2, 3, and 12. At the initial visit
the following will be recorded: birth year, gender, ethnicity, race, women of child bearing
age: current form of birth control, negative or positive urine Hcg, current medications
(medication, dose, frequency, diagnosis), allergies, past or present medical problems, height
and weight, HbA1c value, wound site, wound etiology, Blood pressure, pulse, and if the
subjects will be randomized into either the control or supplementation group. Subjects will
return one week later for study visit one where their blood pressure and pulse will be
recorded and will also have one of the following tests completed as a screen fail for the
study: Transcutaneous Oxygen Measurement, Toe Pressure, or Ankle-Brachial Index Test. If the
reading is inadequate then the subject will no longer participate in the study. Their wound
vac sponge will be collected and imaging will be obtained. Subjects will return for study
visit 2 where they will have their blood pressure and pulse recorded, will have a blood draw,
wound vac sponge collected and wound imaging obtained. Subjects will be asked to return after
12 weeks of supplementation and will have their blood pressure and pulse recorded and wound
imaging obtained. Subjects will be asked to bring any empty packets of the supplement to each
visit for compliance and will be given a new supply of supplements at the initial visit,
visit 1 and 2. Note, if a subject is discontinued from the negative pressure therapy within 2
weeks of consent then the subject will be dropped from the study.

Inclusion Criteria:

- Patients 30 - 70 years

- Patient must understand and give written informed consent

- Patient must be a Type II Diabetic

- HbA1c ≤9%

- Receiving Negative Pressure Therapy (NPWT)

One or more of the following:

- Transcutaneous Oxygen Measurement >30 mmHg

- ABI (Ankle-Brachial Index) >0.7 and less 1.3

- Toe Pressures >30 mmHg

Exclusion Criteria:

- Individuals who are deemed unable to understand the procedures, risks and benefits of
the study, i.e. Informed consent will be excluded.

- Patients who are pregnant (all women of childbearing age will have a urine Hcg test
upon enrollment and agree upon one of the following forms of contraception for the
duration of the study: Abstinence, Hormonal contraception, spermicidal condoms, or
either you or your partner having been surgically sterilized)

- Immuno-compromised patients; receiving radiation therapy, chemo, or have gone through
transplantation or other conditions with prolonged steroid use

- Patients with clinical signs of soft tissue infection such as fever, erythema,
leukocytosis, purulent drainage.

- Antibiotic use 7 days prior to biopsy and cultures

- Current smoker

- Clinically significant kidney or liver disease (dialysis)

- Severe neurologic dysfunction

Females who are pregnant as well as individuals who are therapeutically immuno-compromised
will also be excluded in order to minimize the risk to such individuals (and fetus) and to
decrease statistical variability and to minimize potential of confounders.