Objective: To evaluate the healing rate of venous leg ulcers treated with Promogran. Method: Patients with stagnating venous leg ulcers were recruited. Target wounds were ≥2cm but ≤10cm in any one dimension. Subjects were randomly allocated to receive either Promogran or a non-adherent dressing (Adaptic) with a secondary dressing of gauze followed by short-stress compression (Biflex). Weekly wound assessments occurred over 12 weeks and dressings were changed twice weekly by the investigator and/or nurse team. Planimetry tracings and photographs were blindly reviewed and assessed by two independent investigators. An intent-to-treat analysis was performed. Results: Seventy-three patients were included. Thirty-seven were randomly allocated Promogran and 36 Adaptic. Twenty-nine patients completed the 12-week follow-up visit, 25 healed before week 12 and 19 stopped follow-up before week 12 for reasons unrelated to healing. Significantly more patients in the Adaptic group than in the Promogran group switched to another dressing (22.2% versus 5.4%; p=0.035). Eleven venous leg ulcers healed in the control group (31%) and 15 in the Promogran group (41%) (p=0.373). Overall, 15 venous leg ulcers healed or improved in the control group (42%) and 23 in the Promogran group (62%) (p=0.079). Surface area decreased, on average, by 36.5 ±11.4% (median decrease: 44.6%) in the Adaptic group and by 54.4 +10.9% (median decrease: 82.4%) in the Promogran group (p<0.001). A ≤20% surface area reduction was observed in 15 patients in the Adaptic group and in seven in the Promogran group (42% versus 19%; p=0.034). No severe local adverse events were noted in either group, although poor tolerability caused a dressing switch in five patients in the control group and three in the Promogran group. Dressing acceptability was good or excellent in more than 60% of subjects in both groups. Conclusion: The results suggest that Promogran may accelerate healing in venous leg ulcers and was well tolerated compared with the current standard of care. Declaration of interest: This study was funded by Johnson and Johnson Wound Management, France.

Clinical indicators such as simple ulcer length measurement and ulcer duration may help physicians to detect patients with a prognosis of poor healing.

This new two-bandage compression system is effective and well accepted by patients.

On a short-term basis, concordance with compression can be substantially improved by simple measures with a clear favourable consequence on both ulcer status and peri-ulcer skin aspect when a non-adherent primary dressing is used. However, the acceptability of compression to patients is poor, and continuous effort is required to convince them of its importance.

Treatments with estrogens and progestogens are suspected of causing vascular complications either directly or by metabolic consequences. Although many studies have demonstrated an increased incidence of arterial and deep venous thrombosis, since 1970 the dose of estrogens and progesterones have been lowered with a proportional lowering of side effects. After classification of estrogens and progestogens, we studied their peripheral vascular effects. In our study, we demonstrated that the effects of estroprogestogen treatment on the superficial venous system depend on the dose of estrogen and progestogen.