Breaking Barriers in Peripheral Artery Disease (PAD) and Diabetic Foot Ulcer (DFU) Care

Peripheral Artery Disease (PAD) is one of the most significant risk factors for diabetic foot ulcers (DFUs), contributing to poor healing outcomes and increased amputation risk. For clinicians, managing PAD-related wounds remains a challenge—especially in resource-limited healthcare settings.

Recent clinical research highlights how Continuous Topical Oxygen Therapy (cTOT) and telehealth technology can transform care for patients with PAD and DFUs by overcoming access barriers and improving healing rates.

The Burden of PAD and DFUs

  • Up to 43% of patients with DFUs also have PAD, creating a double burden of poor circulation and high chronicity.¹
  • The annual incidence of DFUs is 6% in the U.S. Medicare population and 5% in U.S. Veterans.2
  • Many diabetic patients suffer from distal PAD with medial artery calcification (MAC), further reducing oxygen delivery to tissues.3

These combined factors lead to slower wound healing, higher wound recurrence rates, and greater risk of limb loss.3 4

Why Oxygen Matters in PAD Wound Healing

In patients with Peripheral Artery Disease, oxygen delivery to wound tissue is severely compromised. Without oxygen, critical healing processes—including angiogenesis, fibroblast activity, and collagen synthesis—cannot occur efficiently.

Up to 43% of patients with DFUs also have PAD (Peripheral Artery Disease), creating a double burden of poor circulation and high chronicity
PAD and diabetic foot ulcer wound healing with oxygen therapy

Continuous Topical Oxygen Therapy (cTOT), such as NATROX® O₂, provides oxygen directly to the wound bed, helping to:

  • Enhance antimicrobial efficacy
  • Increase ATP production which allows the white blood cells to function properly
  • Stimulate new blood vessel growth
  • Promote granulation tissue and re-epithelialization
  • Accelerate wound closure
  • Counteract the effects of poor perfusion in Peripheral Artery Disease

Clinical evidence now supports incorporating cTOT as an evidence-based practice in managing DFUs.7

Barriers to PAD and DFU Care

The COVID-19 pandemic exposed major challenges in wound care delivery:

  • Limited access to care due to transportation difficulties and patient reluctance for in-person visits
  • Short staffing in clinics, reducing appointment availability
  • Fragmented care from non-integrated wound-specific software⁵ ⁶
  • PAD patients at high risk, as compromised circulation increases the likelihood of complications due to an impaired immune response and vulnerable tissues.

While telehealth expanded rapidly during the pandemic, most solutions lacked wound-specific technology, leaving clinicians without the tools to effectively monitor DFUs remotely.⁵

Risk of Amputation from Infection: Vulnerable Tissues due to lack of blood flow- PAD (Peripheral Artery Disease)
Risk of Amputation from Infection: Impaired Immune Response exacerbated by PAD (Peripheral Artery Disease)

Clinical Evidence: Dr. Aliza Lee’s Study

At the SAWC Spring 2023 conference, Dr. Aliza Lee, DPM, MS, ABPM (V.A. Hospital, Salem, Virginia) presented a 12-week study on 8 patients with chronic wounds. The study tested a hybrid care model using:

  • NATROX® O₂ Continuous Topical Oxygen Therapy (cTOT)
  • A digital telehealth platform for remote wound monitoring
Continuous Topical Oxygen Therapy (cTOT) and digital health solutions represents a turning point in PAD and DFU care

Results at a Glance

  • 96% average wound size reduction
  • 2 patients healed completely in under 2 weeks
  • Unhealed patients continued on cTOT:
    • 5 went on to heal over an average of 5.2 weeks and 1 patient expired.
  • Hybrid telehealth + cTOT approach removed barriers, reducing the need for face-to-face visits while ensuring consistent care

This study shows that combining cTOT with a digital wound platform can significantly improve outcomes for Peripheral Artery Disease (PAD) and DFU patients.

The Future of PAD Wound Care

The integration of Continuous Topical Oxygen Therapy (cTOT) and digital health solutions represents a turning point in Peripheral Artery Disease (PAD) and Diabetic Foot Ulcer (DFU) care. Key steps for clinicians include:

  1. Early identification of PAD in patients with DFUs
  2. Incorporating Continuous Topical Oxygen Therapy (cTOT) as an adjunctive, evidence-based treatment7
  3. Leveraging telehealth platforms to overcome barriers of access, staffing, and continuity

By adopting these strategies, healthcare providers can deliver more efficient, accessible, and effective wound care—reducing complications and improving healing for high-risk PAD patients.

Improve Healing for High-Risk (Peripheral Artery Disease) PAD Patients

References

  1. Prevalence of Peripheral Arterial Disease in Diabetic Foot Ulcer Patients and its Impact in Limb Salvage. Int J Low Extrem Wounds. June 2021; 22(3). Ahmed Azhar, et al.
  2. Boulton AJM, Armstrong DG, Kirsner RS, et al. Diagnosis and Management of Diabetic Foot Complications. Arlington (VA): American Diabetes Association; 2018 Oct. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538977/ doi: 10.2337/db20182-1
  3. Ferraresi R, Ucci A, Pizzuto A, et al. A Novel Scoring System for Small Artery Disease and Medial Arterial Calcification Is Strongly Associated With Major Adverse Limb Events in Patients With Chronic Limb-Threatening Ischemia. J Endovasc Ther. 2021;28(2):194-207. doi:10.1177/1526602820966309
  4. Tang TY, Mak MYQ, Yap CJQ, et al. An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (Natrox™) on the Rates of Healing of Chronic DiAbetic Foot Ulcers (OTONAL Trial) Int J Low Extrem Wounds. 2021;0(0). doi:10.1177/15347346211053694
  5. Driver VR, Couch KS, Eckert KA, et al. The impact of the SARS-CoV-2 pandemic on the management of chronic limbthreatening ischemia and wound care. Wound Repair Regen. 2022;30(1):7-23. doi:10.1111/wrr.12975
  6. Spotswood S. US Medicine. Severe Staffing Shortages Continue to Plague VA Health System. https://www.usmedicine.com/non-clinical-topics/personnel/severe-staffing-shortages-continue-to-plague-va-healthcaresystem/ Last Modified: April 14,2022. Accessed December 10, 2022.
  7. Serena TE, Bullock NM, Cole W et al, 2021. Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled trial. J Wound Care 2021; 30: Suppl.5 S7-14.