01/19/2026    Allen M. Jacobs, DPM

CMS and Cellular Tissue Products (Paul Kesselman, DPM)

There is an idiom from the California gold rush
days, “There’s gold in them thar hills.” Perhaps a
modern version might go “ There’s money in them
thar grafts.” Do these almost 400 cellular and
tissue products (us older guys still call them
skin graft substitutes ) impact the outcome of
wound management to such an extent that Dr.
Kesselman’s warning of increased amputation rates
without them may be expected?

I think not. A recent examination concluded that
CTP’s may expedite the healing of some wounds, a
recent meta/analysis concluded that indeed CATP’s
reduce healing time and are associated with a
greater percentage of healed diabetic foot ulcers
when compared to controls (Lu, et al., JVS
vascular Insights Vol, 4, 2025). Numerous meta-
analyses and other summaries and position papers
express a similar conclusion.

Why then my personal skepticism?

Most studies on wound care products have inclusion
criteria for the study. For example, a patient may
not enter the study with poor renal function or
PAD, or if they are a smoker, or have poorly
controlled diabetes, and so on. In essence, many
studies “ cherry pick “ those eligible for the
study. Are these reflective of the “ take all
comers “ that we care for in daily practice? In
actual practice we treat patients with multiple
comorbid conditions, controlled or uncontrolled.
Given these impediments to healing, do we expect
CTP’s to enhance wound healing? The answer, we do
not know.

There is the issue of the nature of the wounds.
How many of these products are proven to be
effective in deep wounds with bone or joint
exposure or infection? The majority are studies on
more superficial wounds, not the extensive, deep
necrotic wounds we encounter in practice. These
are the patients at risk for amputation or sepsis,
generally not the superficial non infected wounds
on which the majority of these products are
studied.

Changing end points are another issue. It’s
wonderful that rate of closure may be more rapid,
but I want healed, not better Healjng in the first
four weeks.

CTP’s are usually combined with “standard wound
care”. Meaning a saline compress, gauze, and off-
loading. Is that all you typically offer for your
wound care? Probably not.

There is significant bias in many of these
studies. Corporate sponsored research is 3.5X more
likely to demonstrate product effectiveness. That
is reality.

Wound care product manufacturers dominate podiatry
education. They provide paid speakers at many
meetings. They provide “ free workshops “ showing
you the technique of opening a package and putting
the product on a wound. They sponsor dinner
meetings. They bring food to your offices.
Consultants and speakers make tremendous money
lecturing for these product manufacturers. The
companies court students and residents. As a
result there is acceptance of these products and
irrational use.

Many of these products are expensive. Salespeople
for these products seem to emphasize the profit
per unit more than the scientific basis for
selecting these products. Health care providers
seem to use the most profitable products, moving
from product to product as more lucrative products
become available.

There are well over 350 CTP’s. Most are cleared
for use without rigorous studies because they are
classified as somehow “equivalent” to human skin.
How can this many products all work to lower
amputation rates and heal ulcers in 70, 80, 90% of
wounds. So say those collecting speaking and
consulting fees for hawking these products. Does
it say stupid on my forehead as I walk about an
exhibit hall at a wound care meeting? Why have
amputation rates not plummeted with all of the
fabulous products?

If you want to know why Medicare has put an end to
exploitation of the gold in them thar hills these
are the reasons why. Everyone knows abuse is
rampant. There is one doctor ( a podiatrist ) whom
I know for a fact bills $750,000 per WEEK doing
wound care. You read that correctly. PER WEEK.
Another $300,000 PER WEEK doing wound care. You’d
think it would take an act of Congress to pay
these guys.

The goose might lay the golden eggs, but if you
grab it by the neck and strangle it there is no
more goose. And no more golden eggs.

Don Meredith, former Dallas Cowboys quarterback
(Yeech) used to sing on Monday night football at
the time it was obvious a team was going to lose
the following;

Turn out the lights, The party’s over.
They say that all good things must come to an end.

Allen Jacobs, DPM, St. Louis, MO

There are no more messages in this thread.