✦ Randomized Controlled Trial
Original Figure 1 (CONSORT Flow Diagram) & Figure 2 (Wound Area Reduction)
Original Figure 3A–C: Kaplan–Meier Curves for Infection Resolution, 10% Reduction, and 20% Reduction
Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial
JAMA Network Open (2020) · Diabetes and Endocrinology
Journal: JAMA Network Open (2020) · Section: Diabetes and Endocrinology
DOI: 10.1001/jamanetworkopen.2020.10411
Citation: Stratmann B, Costea TC, Nolte C, et al. Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Network Open. 2020;3(7):e2010411.
Key Findings
30.5% vs 55.2%
Residual wound area in CAP group vs placebo. CAP reduced wound area by nearly 70%.
P = 0.03 *
−26.31 relative units
Difference in wound area reduction between CAP and placebo (mixed-model estimated mean).
95% CI, P = 0.03
10% reduction — significantly earlier
All wounds in the CAP group achieved ≥10% reduction; 3 placebo wounds never did.
P = 0.01 *
20% reduction — significantly earlier
CAP group reached 20% wound area reduction significantly faster (accelerated failure time model).
P = 0.001 **
📊 Primary Endpoint: Wound Area Reduction
100%
75%
50%
25%
0%
30.5%
CAP
55.2%
Placebo
P = 0.03 *
Residual Wound Area After Treatment
CAP group residual 30.5% (95% CI: 12.3%–53.5%), placebo group residual 55.2% (95% CI: 25.2%–72.0%). Estimated mean difference −26.31 ± 11.72.
Original Figure 1 (CONSORT Flow Diagram) & Figure 2 (Wound Area Reduction)
📈 Secondary Endpoint: Time to Wound Reduction (Kaplan–Meier Curves)
Accelerated failure time model analysis. Median time to wound reduction was significantly shorter in the CAP group compared to placebo.
Original Figure 3A–C: Kaplan–Meier Curves for Infection Resolution, 10% Reduction, and 20% Reduction
