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Updated: Feb 10, 2026

Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
A prospective, observational study of high-specification foam immersion surfaces used in populations at high risk for
Susan Girolami1, Angelene Moore2, Casey Haper3
1Therapy Support, Inc, Cincinnati, OH;
Abstract:
There are insufficient clinical outcomes data to select pressure redistribution support surfaces for vulnerable populations at risk for skin breakdown. A prospective, descriptive case series study with historical controls was conducted to examine clinical outcomes and user feedback when non powered, ergonomically designed, high-specification foam (HSF) devices were added to either a medical grade portable recliner or standard hospital bed used in the care of persons at high risk for pressure ulcers (PU). The study was conducted in a hospice agency and a VA rehabilitation and long-term care unit. Eligible participants were mobility and/or activity impaired; had at least one comorbidity; received standardized skin hygiene, incontinence, and repositioning protocols; and/or had previously documented negative outcomes (eg, pain or discomfort associated with sitting or lying surfaces, falls from equipment, nonhealing PU, and posturing problems such as leaning, sliding, or slumping) on currently used support surfaces. Patients/caregivers ranked pretrial and trial surface performance for overall comfort, control of downward migration, overall immersion, support while sitting without bottoming-out or hammocking, and heel off loading as evidenced by suspension or total immersion of the foot and ankle. Follow-up variables, including changes in pain, discomfort, PU status (if present), and skin integrity, were obtained every 7 to 21 days. Forty-four (44) persons (24 men, 20 women; average age 79, range 47-98 years) participated in the mattress study for an average of 53 (range 3-120) days); and 33 (eight men, 25 women; average age 82, range 63 to 97 years) participated in the recliner support system evaluation, for an average of 39 days (range 13-66 days). Compared to prestudy surfaces, perceived comfort, migration, immersion, and heel off loading ratings were significantly higher for the mattress and recliner surface (P <0.05). No falls occurred, and 17 of 35 preexisting PU in the mattress and 17 of 20 PU in the seating surface group healed. Two of 26 hospice patients developed a new end-of-life, Stage II PU after day 48 of the mattress trial. No new PU developed in the seating trial. These results suggest randomized comparative studies comparing these non powered HSF chair and bed surfaces to other commonly used support surfaces are warranted.
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