Use of Droplette Micromist Technology Device (DMTD) for Deep Tissue Treatment of Pressure Ulcers

llion people per year and costs over $26 billion (1-11). Pressure Ulcer (PU) is major disease burden to the US military and civilian populations and identifying new treatments for PUs is a priority for DoD (1-11). Despite significant advances in the development of gene and protein therapy and tissue-engineered skin substitutes to treat pressure ulcers (PUs), inability to achieve complete healing of PUs in advanced stages (Stage-3 and Stage-4) when bone and muscle are damaged in addition to skin in the PU, and prevent PU recurrence, remain the greatest challenge for physicians and patients (1-11). Thus, the overarching goal of this DoD-funded project is to develop a new deep tissue treatment that delivers nucleic acid and protein therapeutics directly to deep tissues in the wound bed of pressure ulcers (PUs) within seconds to activate deep tissue repair. We expect that such a treatment will achieve complete healing of advanced PUs (Stages 3 and 4), prevent PU recurrence, and improve patient outcomes. 

Inclusion Criteria

1. All patients who undergo above knee or below knee amputation at Tufts. 

Exclusion Criteria

1. Subjects unable to consent- Competency will be determined by the PI in collaboration with the subject’s surgeon on the basis of whether the subject would be considered by the physician to be able to provide consent for any routine medical or surgical procedure. If a health proxy is consenting on behalf of the patient, we will discuss the study with them. 2. Pregnant patients 

Study Requirements

There is only one research visit which is at the time of the amputation surgery, and the length of participation is only at the time of surgery. From the discarded tissue, we will take the skin tissue and code them.