An Open-Label, Randomized Study Comparing Efficacy and Safety of Intravenous Piperacillin/Tazobactam and Ampicillin/Sulbactam for Infected Diabetic Foot Ulcers

2005 ◽  
Vol 6 (1) ◽  
pp. 27-40 ◽  
Author(s):  
Lawrence Harkless ◽  
Jack Boghossian ◽  
Richard Pollak ◽  
Wayne Caputo ◽  
Adrian Dana ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Randomized Study ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Efficacy And Safety ◽  
Open Label

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

2021 ◽  
Vol 30 (Sup5) ◽  
pp. S7-S14
Author(s):  
Thomas E Serena ◽  
Neal M Bullock ◽  
Windy Cole ◽  
John Lantis ◽  
Lam Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Wound Closure ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Number Of Patients

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

033
A Pilot Randomized Study of the Treatment of Diabetic Foot Ulcers with a Bioactive CoPolymer, E-Matrix

2008 ◽  
Vol 13 (2) ◽  
pp. A4-A27
Author(s):  
W.A. Marston ◽  
P.A. Blume ◽  
P. Dardik ◽  
I. Gordon ◽  
J.R. Hanft ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Randomized Study ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers

scholarly journals An open‐label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis

2019 ◽  
Vol 27 (6) ◽  
pp. 680-686 ◽  
Author(s):  
William A. Marston ◽  
John C. Lantis ◽  
Stephanie C. Wu ◽  
Aksone Nouvong ◽  
Tommy D. Lee ◽  
...  
Keyword(s):  
Umbilical Cord ◽  
Diabetic Foot ◽  
Foot Ulcers ◽  
Human Umbilical Cord ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Open Label Trial

Efficacy and Safety Evaluation of Systemic Extremely Low Frequency Magnetic Fields Used in the Healing of Diabetic Foot Ulcers–Phase II Data

2015 ◽  
Vol 46 (6) ◽  
pp. 470-478 ◽  
Author(s):  
Luis Cañedo-Dorantes ◽  
Luis R. Soenksen ◽  
Clara García-Sánchez ◽  
Daphny Trejo-Núñez ◽  
Fernando Pérez-Chávez ◽  
...  
Keyword(s):  
Magnetic Fields ◽  
Phase Ii ◽  
Diabetic Foot ◽  
Low Frequency ◽  
Safety Evaluation ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Efficacy And Safety ◽  
Extremely Low Frequency

scholarly journals Spray on skin for diabetic foot ulcers: an open label randomised controlled trial

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Laurens Manning ◽  
Emma J. Hamilton ◽  
Edward Raby ◽  
Paul E. Norman ◽  
Wendy Davis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Wound Healing ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Economic Benefits ◽  
Complete Healing ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Open Label

Abstract Background One Australian loses a limb every 3 h as a result of infected diabetic foot ulcers (DFU). This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for the health sector and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs. Methods One hundred and fifty eligible participants will be randomised to receive an autologous skin cell suspension, also termed ‘spray-on’ skin (ReCell®) or standard care interventions for their DFU. The primary outcome is complete wound healing at 6 months, but participants will be followed up for a total of 12 months to enable secondary outcomes including total overall costs, ulcer free days at 12 months and quality of life to be assessed. Discussion Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Shortened healing times may enable participants to return to work earlier. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12618000511235. Registered on 9 April 2018.

scholarly journals Plectranthus amboinicusandCentella asiaticaCream for the Treatment of Diabetic Foot Ulcers

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Yuan-Sung Kuo ◽  
Hsiung-Fei Chien ◽  
William Lu
Keyword(s):  
Diabetic Foot ◽  
Statistical Significance ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Safe Alternative ◽  
Significant Difference ◽  
Grade 3

Effects of a topical cream containingP. amboinicus(Lour.) Spreng. (Lamiaceae) andC. asiatica(L.) Urban (Umbelliferae) were evaluated and compared to effects of hydrocolloid fiber wound dressing for diabetic foot ulcers. A single-center, randomized, controlled, open-label study was conducted. Twenty-four type 1 or type 2 diabetes patients aged 20 years or older with Wagner grade 3 foot ulcers postsurgical debridement were enrolled between October 2008 and December 2009. Twelve randomly assigned patients were treated with WH-1 cream containingP. amboinicusandC. asiaticatwice daily for two weeks. Another 12 patients were treated with hydrocolloid fiber dressings changed at 7 days or when clinically indicated. Wound condition and safety were assessed at days 7 and 14 and results were compared between groups. No statistically significant differences were seen in percent changes in wound size at 7- and 14-day assessments of WH-1 cream and hydrocolloid dressing groups. A slightly higher proportion of patients in the WH-1 cream group (10 of 12; 90.9%) showed Wagner grade improvement compared to the hydrocolloid fiber dressing group but without statistical significance. For treating diabetic foot ulcers,P. amboinicusandC. asiaticacream is a safe alternative to hydrocolloid fiber dressing without significant difference in effectiveness.

Efficacy of Maggot Debridement Therapy on Refractory Atypical Diabetic Foot Ulcers: An Open-Label Study

2020 ◽  
pp. 153473462092040
Author(s):  
Mansour Siavash ◽  
Ali Najjarnezhad ◽  
Nader Mohseni ◽  
Seyed Mohammad Abtahi ◽  
Azadeh Karimy ◽  
...  
Keyword(s):  
Wound Healing ◽  
Diabetic Foot ◽  
Bacterial Infections ◽  
Healing Time ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Major Health Problem ◽  
Maggot Debridement Therapy ◽  
Complete Wound Healing

Atypical or refractory diabetic foot ulcers (DFUs) are still a major health problem. Maggot debridement therapy (MDT) by larva of Lucilia sericata is an ancient and a modern option for wound healing. It works by debridement, stimulation of wound healing, and disinfection. In this study, we aimed to evaluate the efficacy of MDT for healing atypical and refractory DFUs. Patients with atypical DFUs were selected and further evaluated for some predefined differential diagnoses like atypical fungal, parasitic, or bacterial infections, malignancy, trauma, and so on. Multiple MDT sessions were carried out. Ulcer size was measured before every MDT session. Complete wound healing, time to heal, and adverse effects were recorded as well. Forty-two DFU patients (26 men, 16 women) with 42 nonhealing atypical ulcers participated in this study. Complete wound healing was achieved in 35 patients (83.3%) by MDT. Complete debridement and then healing of the wounds happened in less than 1.79 ± 0.8 months. Four ulcers persisted, and 3 (7.1%) were eventually amputated. MDT may be considered as an effective treatment for atypical DFUs, which are unresponsive to conventional therapies.

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