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Pneumatic Medicine: A Transformative Approach to Chronic Wounds

Laura F. Jacobs, MD, PhD
December 2010

  Standard treatment to heal a single chronic wound typically averages more than six months of intensive effort with costs exceeding an unsustainable $27,000.1 Even more problematic, standard care does little to avoid wound recurrence, which is often well over 70%.2 The challenge only increases with an aging population and the epidemic rise in co-morbidities associated with non-healing wounds including diabetes and obesity.

  Accordingly, a new conceptual and treatment paradigm is urgently needed, one offering rapid healing, a major drop in wound recurrence and significantly lower costs to patients, insurers and the community.

Current Treatment

  Various conceptual approaches to healing chronic wounds inform the current vast array of wound care products, with treatments focused mainly on improving the wound environment. These approaches include, for example, viewing chronic wounds as entities arrested in cellular senescence requiring transformation into acute wounds to trigger anew the healing cascade. Other thinking stresses maintaining moist wound environments to encourage epidermal cell migration, or utilizing topical protein matrices to establish cellular scaffolding for healing.

The Basic Question

  While improving the wound environment is important, largely missing in wound care thinking is the basic question: why do most wounds initially develop and then fail to heal quickly, if at all? The answer is poor peripheral circulation—arterial, venous, and/or lymphatic—particularly at the micro-vessel level.

  Absent sufficient oxygenation and dynamic movement of nutrient-rich blood throughout the entire circulatory system, cell waste and metabolic byproducts stagnate in the tissues, interrupting normal wound healing. Put simply, patients with good micro-vascular circulation may develop wounds—from trauma, for example—but tend to heal quickly; patients with poor microcirculation don’t. Even patients with large-vessel arterial defects who successfully undergo vascular procedures still experience delayed wound healing due to concomitant micro-vascular compromise.

  In sum, re-thinking current conceptual approaches to wound care treatments is needed to significantly speed healing and meet the challenge.

Pneumatic Medicine: A New Conceptual and Treatment Paradigm

  Pneumatic Medicine3 shifts the focus from merely improving the wound micro-environment to formally treating the underlying micro-vessel circulatory compromise as part of an extremely simple, cost effective clinical protocol.

  Clinical results for patients treated with Pneumatic Medicine are compelling: rapid, complete wound closure, even for lesions of long standing, and marked reduction in wound recurrence. Most important, the existing technology is covered by Medicare and private insurers.

  Pneumatic Medicine uses a pneumatic compression device (“PCD”) to apply external, dynamic (vs. static or non-moving) compression that enhance compromised peripheral circulation. Its design is based on bio-mimicry, which emulates biological models and processes to solve human problems. The PCD’s novel dynamic peristaltic pulse compression algorithm, or pneumatic waveform, combines the physiologic concepts of peristalsis, the simulation of the muscle pump via pulsing compression, and the gradient directionality of flow created by the one-way lymphatic and venous valves in healthy individuals. The waveform speeds slowed micro-circulation, reduces tissue edema, and permits more normal oxygenation and the removal of metabolic byproducts and cellular debris. Healing proceeds quickly—often in days. Wound recurrence significantly diminishes, and is often eliminated long-term, with a concomitant drop in the incidence of cellulitis. With peristaltic pulse compression, practice management options widen considerably, and fiscal and patient outcomes progress measurably.

Pneumatic Medicine offers an intuitive, physiologically based conceptual approach to wounds: with significantly improved micro-circulation, wounds heal and don’t recur. The approach has several features:

  1. Categorizing a wound as arterial or venous is not a significant distinction for treatment with the PCD since peristaltic pulse compression improves blood flow throughout the venous, lymphatic, and arterial micro-vasculature.

  2. The physiologic compression moves interstitial edema back into the vasculature. This reduces overall tissue pressure, opens functionally closed arterioles to allow better perfusion to the tissue and permit antibiotics to readily reach their destination, all of which encourages wound healing.

  3. Even in the absence of edema, wounds heal quickly, likely because the physiological peristaltic pulse compression waveform generates the production of nitric oxide, a powerful systemic smooth muscle vasodilator. Most interestingly, patients with diabetes indicate that in addition to wound healing, their symptoms of peripheral neuropathy—burning dysesthesias and insensate feet—actually appear to reverse with Pneumatic Medicine treatment. The clinical explanation is further hypothesized that with enhanced micro-circulation, peripheral nerve function improves. Indeed, patient and prescriber self-reports were so compelling that an NIH-funded study is now on-going to scientifically document these outcomes in a double blind prospective clinical trial.

Treating Wounds With Pneumatic Medicine

  With this conceptual base, Pneumatic Medicine offers a radically simple 4-part protocol to heal even the most challenging wounds:

  1. Use of the peristaltic pulse compression device an average of an hour daily at home.

  2. Limb and wound daily cleansing (eg, in a shower) and skin moisturizing.

  3. Appropriate antibiotics to treat the wound’s bacterial bioburden and biofilm.

  4. The avoidance of static (or non-moving) external compression that often inhibits vascular flow, along with making sure all dressings are non-occlusive to prevent peri-wound maceration and to inhibit the growth of anerobes.

Expected Outcomes

  Anecdotal experience has demonstrated that strict adherence to this protocol offers rapid, complete wound closure. Additionally, patients continue using the device after healing to maintain the underlying circulation, thus significantly reducing wound recurrence. With further clinical experience and formal research, it is anticipated that Pneumatic Medicine will indeed meet the challenge of rapidly healing chronic wounds in a truly cost effective manner.

  Laura F. Jacobs, MD, PhD (bioengineering) is the former chief of the department of Physical Medicine and Rehabilitation at Cooper Hospital/University Medical Center. She is currently the President & CEO of NormaTec, a company devoted to developing non-invasive solutions to peripheral vascular and related conditions based in Newton Center, MA.

References

1. Harding, K., Morris, H., Patel, G.: Science, medicine and the future: healing chronic wounds. BMJ 324(7330), 160-163 (2002)

2. Black, S.: Venous stasis ulcers: a review. Ostomy Wound Manage 41(8), 20-30 (1995)

3. Jacobs, L.: Definition of Pneumatic Medicine: The use of non-invasive, dynamic compression to treat the array of peripheral vascular diseases including chronic wounds, (1998)

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