Negative pressure wound therapy efficient treatment option to Standard moist wound care for diabetic foot wounds: DiaFu trial

Diabetic foot ulcers not only have a negative impact on patient mortality, morbidity and quality of life, but also require high resource utilization to achieve complete wound healing.

Dorthe Seidel et al conducted a study to compare resource utilization of negative pressure wound therapy (NPWT) and standard moist wound care (SMWC) for diabetic foot wounds after amputation, surgical debridement or wound cleansing.

The multicenter clinical DiaFu study enrolled 368 adults with diabetic foot ulcers. Patients were randomly assigned to NPWT and SMWC. Evaluation of direct resource use comprised inpatient and outpatient treatment time, and personnel and material for wound treatment within 16weeks. This resource use analysis was primarily based on the per protocol population (NPWT 44; SMWC 110).

Prior to randomization and initiation of study treatment, patients received either a surgical debridement, an amputation of foot parts, or a thorough wound cleansing, depending on the individual wound needs, to allow clear assessment of the wound and to provide optimal conditions for study treatment with the aim of complete wound healing. Amputations involved part or the entire study wound, changing the chronic state to an acute condition.

In the intervention arm, commercially available CE marked NPWT devices of the participating manufacturers were used in the discretion of the clinical investigator in compliance with manufacturers' recommendations for use. Intermittent and continuous NPWT was allowed to be used with the negative pressure to be adapted as recommended for the dressing applied and adapted to the wound needs. NPWT as interim therapy was discontinued once the condition of a wound was suitable either for surgical closing or for healing by epithelialization.

Control therapy was SMWC, which was any local wound treatment regularly used in the respective study site that did not have an experimental status or was NPWT. SMWC was applied according to the hospitals' local clinical standards and guidelines, based on the individual needs of the wound in the process of healing, and with special attention paid to exudate amount and local infection stat

Key findings of the study were:

• Treatment duration was 16days shorter with NPWT (mean (SD) 82.8 (31.6), SMWC 98.8 (24.6); U test, p=0.001) with 14.9days shorter outpatient treatment (mean (SD) NPWT 68.3 (31.1), SMWC 83.2 (29.7)).

• The number of dressing changes per study participant was lower with NPWT (mean (SD) 35.1 (18.6), SMWC (42.9 (21.4); U test, p=0.067).

• Time per dressing change was significantly lower with SMWC (mean (SD) 19.7 (12.8), NPWT (16.5 (8.2) minutes; U test, p< 0.0001).

• Time for surgical debridements per study participant was 23.3minutes shorter with NPWT (mean (SD) 20.5 (20.5), SMWC (43.8 (46.7); U test, p=0.395).

The authors concluded that – "Resource use was lower for NPWT, which may be an efficient treatment alternative to SMWC for diabetic foot wounds, to be demonstrated in subsequent cost analyses."

Further reading:

NPWT resource use compared with standard moist wound care in diabetic foot wounds: DiaFu randomized clinical trial results

Dorthe Seidel, Rolf Lefering and DiaFu study group

Journal of Foot and Ankle Research (2022) 15:72

https://doi.org/10.1186/s13047-022-00569-w