Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study.
Panthenol
Royal Jelly
diabetic foot ulcers
limb threatening
local treatment
Journal
Diabetes, metabolic syndrome and obesity : targets and therapy
ISSN: 1178-7007
Titre abrégé: Diabetes Metab Syndr Obes
Pays: New Zealand
ID NLM: 101515585
Informations de publication
Date de publication:
2019
2019
Historique:
received:
31
03
2019
accepted:
30
07
2019
entrez:
1
10
2019
pubmed:
1
10
2019
medline:
1
10
2019
Statut:
epublish
Résumé
Diabetic foot ulcer (DFU) is the main risk factor for nontraumatic lower-limb amputation. We hypothesized that by reversing the offending local tissue factors resulting from the low tissue supply of oxygen, inefficient fuel metabolism and acidosis, we can eradicate the infection and help to promote healing. This might be enhanced with the help of an innovated local preparation (PEDYPHAR A prospective, randomized, controlled open-label study design with a mean follow-up period of 12 weeks. One hundred and nineteen eligible patients with diabetic foot wounds presenting to 3 outpatient clinics in Egypt were randomized to be treated with the local application of either PEDYPHAR or Panthenol ointment under dressing after conservative debridement of necrotic tissue and irrigation with warm normal saline. At the end of the 12-week follow-up period, PEDYPHAR showed a higher rate of complete healing of limb-threatening wounds in the intent-to-treat population, 11 of 34 (32.4%) in PEDYPHAR-treated group versus 3/25 (12%) in the Panthenol-treated (control) group ( We can conclude that PEDYPHAR could be an effective and safe conservative local adjuvant treatment for cases of diabetic foot infection.
Sections du résumé
BACKGROUND
BACKGROUND
Diabetic foot ulcer (DFU) is the main risk factor for nontraumatic lower-limb amputation. We hypothesized that by reversing the offending local tissue factors resulting from the low tissue supply of oxygen, inefficient fuel metabolism and acidosis, we can eradicate the infection and help to promote healing. This might be enhanced with the help of an innovated local preparation (PEDYPHAR
METHODS
METHODS
A prospective, randomized, controlled open-label study design with a mean follow-up period of 12 weeks. One hundred and nineteen eligible patients with diabetic foot wounds presenting to 3 outpatient clinics in Egypt were randomized to be treated with the local application of either PEDYPHAR or Panthenol ointment under dressing after conservative debridement of necrotic tissue and irrigation with warm normal saline.
RESULTS
RESULTS
At the end of the 12-week follow-up period, PEDYPHAR showed a higher rate of complete healing of limb-threatening wounds in the intent-to-treat population, 11 of 34 (32.4%) in PEDYPHAR-treated group versus 3/25 (12%) in the Panthenol-treated (control) group (
CONCLUSION
CONCLUSIONS
We can conclude that PEDYPHAR could be an effective and safe conservative local adjuvant treatment for cases of diabetic foot infection.
Identifiants
pubmed: 31564933
doi: 10.2147/DMSO.S210680
pii: 210680
pmc: PMC6731465
doi:
Banques de données
ClinicalTrials.gov
['NCT01531517']
Types de publication
Journal Article
Langues
eng
Pagination
1659-1665Informations de copyright
© 2019 Yakoot et al.
Déclaration de conflit d'intérêts
MY had conducted clinical studies for Pharco. SH is employeed by and holds stocks in Pharco. The authors report no other conflicts of interest in this work.
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