Randomized Clinical Trial to Compare Cryopreserved and Lyopreserved Umbilical Cord Tissue to Treat Complex Diabetic Foot Wounds.
Lawrence A Lavery, Mehmet A Suludere, Matthew J Johnson et al.
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In 30 seconds
This single-blinded, 12-week randomized clinical trial compared cryopreserved (CPUT) with lyopreserved (LPUT) amniotic cord tissue in patients with complex diabetic foot wounds extending to tendon, muscle, or bone. The groups did not differ significantly in wound closure (36.8% vs 19.0%, P = .21) or infection (10.5% vs 4.8%, P = .60). Wound area and volume reductions and closure trajectories were also similar. The findings indicate comparable outcomes for the two tissue preparations over the trial period, without establishing that either is superior.
Key findings
- Wound closure occurred in 36.8% with CPUT and 19.0% with LPUT (P = .21).
- Infection rates were 10.5% with CPUT and 4.8% with LPUT (P = .60).
- Mean wound area reduction was 75.9 ± 32.3% with CPUT and 65.5 ± 38.4% with LPUT (P = .41).
- Mean wound volume reduction was 85.0 ± 30.8% with CPUT and 79.9 ± 31.9% with LPUT (P = .61).
Why it matters
Complex diabetic foot wounds can involve deep tissue and infection, making wound closure and infection important outcomes when evaluating tissue-based treatments. This trial directly compared two preservation methods and found no statistically significant differences across the reported outcomes. The results help frame the evidence as showing similar observed outcomes, rather than demonstrating superiority of one preparation.
What to keep in mind
Follow-up was limited to 12 weeks, and the trial excluded patients with severe perfusion deficits, untreated osteomyelitis, or autoimmune diseases, limiting applicability to those groups.