Page 96 - JCTR-11-2

Journal of Clinical and
Translational Research Biomimetic matrix used to treat diabetic foot ulcers

a higher percent closure rate than patients 1, who received Although not intended to be part of our analysis, the
a lower number of BMM applications. outcomes from our initial patient cohort are of value added.
The treatment length ranged from 5 to 11 weeks, with one The initial eight wounds showed significant progress for
patient achieving full wound closure at 6 weeks following most part of the study. The wound of patient 1 closed
a single application of BMM. In this cohort of patients by week 14, remained closed for 5 weeks, briefly opened
treated with BMM, a reduction in inflammation followed for a week, and then closed again. This wound remained
closed for >3 months. The wounds of patients 2, 3, and 8
by the presence of granulation tissue was observed early closed completely in 8 – 9 weeks and remained closed for
in the healing process. This was followed by maturation >3 months. The wound of patient 4 closed at week 11 and
of the granulation tissue leading to re-epithelialization. remained closed for >3 months. For patient 5, the wound
Furthermore, odor and drainage were noticeably improved remained open still, even after the wound had decreased
with BMM treatment.
further in the area to 13 cm , and thus the patient was
2
No adverse effects were observed during the treatment subsequently scheduled for vascular intervention. Patient
with BMM, and the product was well-tolerated by all 6’s wound was closed at week 6 and remained closed for
subjects in this study. This is particularly important >3 months. For patient 7, the wound area reduced to 3.5 cm
2
given the concern around potential immunogenicity and but then expanded again; this patient was lost to follow-up.
skin reactions associated with certain peptides. BMM
10
has been subjected to extensive safety testing including 4. Discussion
sensitization and skin irritation studies using relevant In this clinical series, chronic, stalled diabetic lower
animal models as well as human subjects under “worst- extremity wounds were treated with a novel, FDA-approved
case” conditions. As a result, BMM has been approved as a BMM. Besides diabetes, all patients presented multiple
non-sensitizer and non-irritant by the U.S. Food and Drug comorbidities that can negatively impair wound
Administration (FDA). In this small case series study, no healing, such as neuropathy, peripheral vascular disease,
signs of inflammation or irritation were observed, and, in osteomyelitis, and prior partial amputation. Nearly
fact, an improvement in the peri-wound skin appearance all wounds were present for over a year without any
was noted. progression toward healing despite the use of a variety
The number of BMM applications, duration of of biologics, including living cell products, collagen,
treatment, initial and final wound size, initial and final and amniotic-derived membranes, as well as regular
wound depth, and percent change in wound area for each debridement, negative pressure wound therapy, and off-
subject are tabulated in Table 2. Representative pictures of loading when appropriate.
wounds before and after BMM treatment are also shown The wound area was calculated by tracing the wound
in Figure 2. perimeter to calculate the surface area. This was then

Table 2. Number of applications, treatment duration, initial and final wound size, and percent change in wound area of patients
treated with BMM
S. no. Number of BMM Treatment Initial wound Initial wound Final wound Final wound Change in
2
2
applications follow‑up (weeks) size (cm ) depth (mm)* size (cm ) depth (mm)* wound area (%)
Patient 1 2 7 2.72 3 2.12 2 −22.1
Patient 2 1 6 1.20 1 0.12 1 −91.7
Patient 3 3 5 0.44 1 0.08 1 −83.3
Patient 4 2 5 3.00 2 1.90 1 −36.7
Patient 5 1 11 40.5 3 18.2 1 −55.1
Patient 6 1 6 1.50 2 0.00 0 −100.0
Patient 7 3 5 9.80 4 5.77 3 −41.1
Patient 8 2 6 1.04 1 0.21 1 −79.1
Average 1.875 6.4 7.525 2.125 3.55 1.250 −63.6
SD ±0.835 ±2.0 ±13.652 +1.126 ±6.2322 +0.886 ±28.7
Note: *Wound depth is typically highly variable across the surface of the wound and is provided here as an average only, and not specific to any
particular section of the wound.
Abbreviations: BMM: Biomimetic matrix; SD: Standard deviation.

Volume 11 Issue 2 (2025) 90 doi: 10.36922/jctr.24.00063