1. Diabet Med. 2017 Sep;34(9):1309-1317. doi: 10.1111/dme.13402. Epub 2017 Jul 12.

Treatment by a moisturizer of xerosis and cracks of the feet in men and women
with diabetes: a randomized, double-blind, placebo-controlled study.

Gin H(1), Rorive M(2), Gautier S(3), Condomines M(3), Saint Aroman M(3), Garrigue
E(3).

Author information: 
(1)Service de diabétologie, Hospital Haut-Lévêque, 33604, Pessac, France.
(2)Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman,
B-4000, Liège, Belgium.
(3)Institut de Recherche Pierre Fabre, CRDPF, 3 avenue Hubert Curien, BP 13562 - 
31035, Toulouse Cedex 1, France.

AIM: To evaluate a moisturizer containing urea, glycerine and petrolatum for
healing deep open fissures on the feet of people with diabetes. If left
untreated, open fissures, an entry point for bacteria, can lead to infection,
ulceration and further complications.
METHODS: This randomized, double-blind, multicentre study at 19 hospitals,
general practices and diabetologists in France and Belgium included participants 
with diabetes and a deep open target fissure on their heel. Participants were
randomized to test cream or placebo (1 : 1) for 4 weeks. Complete target fissure 
healing after 4 weeks (primary criterion) and 2 weeks, target fissure closure,
overall fissure healing and xerosis were assessed.
RESULTS: Some 167 participants were randomized (80 to test cream; 87 to placebo);
all were included in the efficacy analyses. The percentage of participants with
complete target fissure healing after 4 weeks was higher with test cream than
placebo (46.3% vs. 33.3%): the difference did not reach statistical significance 
(P = 0.088). Fewer participants still had a deep open target fissure with test
cream than placebo, the difference was statistically significant and clinically
relevant after 2 (24.7% vs. 42.7%, P = 0.027) and 4 weeks (6.4% vs. 24.1%, P =
0.002). The difference in overall fissure healing between test cream and placebo 
was significant (P < 0.001) and test cream resulted in greater xerosis
improvement (P < 0.001 and P = 0.002 at 2 and 4 weeks, respectively).
CONCLUSION: The activity of the test cream for treating feet fissures of people
with diabetes was confirmed by an improvement in open fissure healing and
xerosis. The cream was well tolerated.

© 2017 Diabetes UK.

DOI: 10.1111/dme.13402 
PMID: 28627029  [Indexed for MEDLINE]