ClinicalTrialsFinder
RecruitingNot ApplicableNCT05132179

Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan

A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers

Sponsor

Vastra Gotaland Region

Enrollment

202 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer

Summary

202 Diabetic foot ulcers will be cleaned with either Hypochlorous Acid, HClO or Polyhexamethylene biguanide, PHMB twice a week until healed or 24 weeks. Primary objective is to find out if cleaning DFU with HClO is more effective in obtaining complete healing than PHMB.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

  • Diabetes Mellitus type 1 or 2 or due to pancreatitis
  • Foot ulcer since 3 weeks or more
  • Ulcer surface area 9 mm2 or more
  • Age 18 years old or more

Exclusion Criteria13

  • Persons in need of intensive care or dialysis
  • Persons in need of vascular intervention, critically impaired circulation (toe-pressure \< 30 mm Hg)
  • Event of myocardial infarction or stroke during the last three months
  • Debut of atrial fibrillation or heart failure during the last three months
  • Current treatment of malignancy
  • Treatment with corticosteroids with a dose corresponding to 50 mg Prednisolon
  • Severe wound infection according to International Working Group of Diabetic Foot, IWGDF at least two of following signs: body temperature \<36 C or \>38 C, heart rate \>90/minute, respiration rate \>20/minute, LPK \>12x10\^9/L
  • Planned changed residence in the coming 12 months requiring change of clinic for wound treatment during the follow-up time
  • Age under 18 years old
  • Diabetes of MOODY type
  • Current known pregnancy or planned pregnancy next 26 weeks
  • Participation in another clinical trial evaluating any treatment
  • Other reasons judged by the investigator that the patient is unsuitable for participation in the study

Interventions

DRUGDakins Full Strength Solution, 0.5% Topical Solution, HOCl solution

Dakin´s solution is a 50/50 mixture of 1% sodiumhypochlorite and 2% sodiumhydrocarbonate, the mixture is a 0,5% chlorine solution. Dakin´s solution is not used in Sweden on wound. Dakin´s solution is only used in dental care in Sweden.

Locations(1)

NU sjukvarden

Uddevalla, Trollhattan, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05132179

Related Trials

A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers

NCT071592821 location

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

NCT070864431 location

Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.

NCT068107262 locations

A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

NCT066186121 location

Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

NCT056108651 location