The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers

Diabetic lower extremity wounds and venous stasis wounds are two of the most challenging,
costly medical problems of our population. Moreover, the Veterans Affairs population has a
very high percentage of diabetes and venous stasis wounds.

Foot ulcers are the most common reason for a diabetic patient to be admitted to the
hospital, and occur in approx 25% of patients (CDC) with an average stay of 3 weeks and a
cost of 25,000$/ per treatment (21,22, 23). The pathophysiology of diabetic wound healing is
characterized by microcirculatory ischemia and an abnormal wound healing cascade due to
glycosylated cells and proteins.

Venous stasis disease affects 10-35% of the US population (24) and is characteristically
difficult to treat, recurrent and costly. The dermal microcirculation is aberrant with
cellular stasis, capillary leak, edema and prone to chronic wounds. As venous pressures
increase in these patients, there is microcirculatory ischemia which predisposes to wound
formation.

In the skin, the normal wound healing cellular cascade mechanism acts to restore epithelial
components and ends in collagen deposition and scar formation. Imperative to this process is
angiogenesis, cellular signaling, and cellular mitosis. These wound healing processes can be
promoted by stem cell transplantation.

It is now known that lipoaspirate obtained by standard small volume liposunction techniques
contains autologous mesenchymal stem cells. We propose that autologous stem cell
transplantation via lipoaspirate injection to these recalcitrant wounds could be a safe and
effective treatment modality. Because the cellular derangement of both diabetic wounds and
venous stasis wounds is derived from abnormal cell signaling, micro-ischemia and abnormal
capillaries, stem cell treatment which can aid in angiogenesis and cellular signaling may be
a treatment option which is aimed directly at the root cause of the disease.

Aim 1: A prospective, single blinded randomized clinical study will be performed to
determine if the injection of lipoaspirate into diabetic or venous stasis wounds promotes
wound healing or wound closure at a faster rate than conventional treatment.

Rationale: Despite considerable effort, successful healing of diabetic lower extremity
wounds and venous stasis wounds remain as a difficult therapeutic challenge. We will examine
whether autologous lipoaspirate injection is a safe and effective treatment option for
diabetic lower extremity wounds and venous stasis wounds.

Hypothesis: Injection of lipoaspirate subcutaneously around diabetic wounds and venous
stasis wounds will promote wound healing more effectively than conventional treatments.

INCLUSION CRITERIA:

- Patients with diabetic lower extremity wounds or venous stasis wounds present for
more than 6 months whose wounds have failed to heal with conventional medical therapy
will be included.

- Only fully consentable and compliant patients who are already scheduled to undergo
surgical wound treatment or wound debridement in the operating room or in clinic will
be included.

- Only patients with palpable distal pulses will be included.

EXCLUSION CRITERIA:

- Patients with the following criteria will be excluded:

- HIV + patients

- patients on anticoagulants which cannot be stopped or corrected

- patients with cellulitis, infection, osteomyelitis, stage III or IV ulcers,
*those patients with no safe donor site availability and dialysis dependent end
stage renal disease.

- Following normal operating room protocol, anticoagulants and aspirin will be stopped
prior to the procedure.

- Patients will be randomly chosen to enter the intervention arm or the control arm of
the study. Even social security numbers will be chosen to undergo the treatment arm
and odd social security numbers will be chosen to undergo the control arm. After
randomization, the control groups and the intervention groups will be analyzed to
ensure that there are no statistically significant differences in patient profiles
including: albumin levels, hematocrit, smoking status, and Hgb A1C values.

- Both insulin dependent and non-insulin dependent diabetic patients will be included
and Hgb A1C values will be used to ensure both groups are similar.