Negative pressure wound therapy not superior to standard care for chronic diabetic foot ulcers
medwireNews: Negative pressure wound therapy (NPWT) does not improve the closure of chronic diabetic foot wounds compared with current standard treatment in German real-life clinical practice, multicenter trial findings suggest.
The DiaFu study found that the innovative treatment option was not significantly better than standard moist wound care (SMWC) in the primary outcome of wound closure within the maximum treatment time of 16 weeks among 345 participants in the intention-to-treat population.
Wound closure at this point – defined as 100% wound epithelialization, no drainage, no suture material, and no need for wound dressing or adjuvants – was slightly more common in patients randomly assigned to NPWT as opposed to SMWC but rates were low overall, at 14.6% versus 12.1%, and did not significantly differ.
Time to wound healing was shorter with NPWT than SMWC, although this only became statistically significant in the 154 participants in the per-protocol population who strictly adhered to the study guidelines.
Adverse events occurred significantly more often with NPWT than SMWC, in 96 versus 72 patients, respectively, although just 16 of those in the NPWT group were definitively related to the medical device according to the investigators’ assessments.
Dörthe Seidel (Witten/Herdecke University, Köln, Germany) and colleagues note that 127 participants in the NPWT group and 64 SMWC group had missing endpoint documentations, premature therapy cessation, and deviations from the treatment guidelines.
“Missing compliance with therapy guidelines and poor documentation quality led to restrictions in achieving the patient-relevant endpoint [of] complete wound closure and prevents a clear proof of effectiveness,” they report in BMJ Open.
“The question if NPWT is superior to SMWC for treating diabetic foot wounds remains unanswered due to the limitations of the DiaFu study.”
DiaFu recruited 368 adults from 40 German centers who had chronic diabetic foot wounds at least 4 weeks old that went further than superficial ulceration of the skin or subcutaneous tissue but stopped short of midfoot or hindfoot gangrene.
Participants included those with peripheral neuropathy and peripheral arterial occlusive disease, making them a typical mixed-patient population. Wound closure, size, and tissue qualities were blindly assessed using photographs.
The authors note that, despite all its limitations, the study did show that the time until optimal preparation of the wound bed for further treatment to achieve a complete epithelialization was significantly shorter in patients receiving NPWT than SMWC.
“This indicates that NPWT works according to its intended use and has a potential to be an effective treatment option,” they say.
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