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Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
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Characteristics and Outcome for Persons with Diabetic Foot Ulcer and No-Option Critical Limb Ischemia

Marco Meloni1, Valentina Izzo1, Valerio Da Ros2

  • 1Department of Systems Medicine, University of Tor Vergata, Viale Oxford 81, 00133 Rome, Italy.

Journal of Clinical Medicine
|November 25, 2020
PubMed

Insights

Diabetic patients with critical limb ischemia (CLI) and foot ulcers who failed revascularization (NO-CLI) had significantly worse outcomes, including higher amputation and mortality rates, compared to successfully treated patients (ST-CLI). This highlights the severe impact of PAD in this population.

Area of Science:

  • Vascular Surgery
  • Diabetology
  • Cardiology
  • Nephrology

Background:

  • Diabetic foot ulcers and critical limb ischemia (CLI) represent a significant clinical challenge.
  • Lower-limb revascularization is a key component of limb salvage protocols for these patients.
  • Patient outcomes can vary significantly based on the success of revascularization procedures.

Purpose of the Study:

  • To evaluate clinical and vascular characteristics of diabetic patients with foot ulcers and CLI.
  • To compare outcomes (limb salvage, amputation, mortality) between successfully treated (ST-CLI) and no-option (NO-CLI) CLI patients.
  • To identify factors associated with poorer outcomes in the NO-CLI group.

Main Methods:

  • Retrospective analysis of 239 diabetic patients admitted with foot ulcers and CLI.
  • Patients managed with a limb salvage protocol including lower-limb revascularization.
  • Division into ST-CLI (successful revascularization) and NO-CLI (failed revascularization) groups for outcome comparison at 1-year follow-up.

Main Results:

  • NO-CLI patients (25.1%) exhibited higher rates of ischemic heart disease, heart failure, and end-stage renal disease (ESRD) than ST-CLI patients.
  • The NO-CLI group presented with more extensive peripheral arterial disease (PAD), including more affected vessels and distal lesions.
  • 1-year outcomes showed significantly lower limb salvage (13.8% vs. 73.4%), higher amputation (30% vs. 4.5%), and mortality (50% vs. 8.9%) in NO-CLI compared to ST-CLI patients.

Conclusions:

  • Diabetic patients with no-option CLI and foot ulcers demonstrate a more severe PAD pattern.
  • Failed revascularization in this population is strongly associated with significantly worse clinical outcomes.
  • These findings underscore the critical need for effective revascularization strategies and comprehensive management in diabetic CLI patients.

Keywords:
diabetic footfoot ulcerationlimb ischemialower-limb amputationrevascularization

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