Efficacy and Safety of a Hyaluronic Acid-Containing Gauze Pad in the Treatment of Chronic Venous or Mixed-Origin Leg Ulcers: A Prospective, Multicenter, Randomized Controlled Trial

2021 ◽  
Vol 66 (6) ◽  
pp. 147-157
Author(s):  
Jacek Mikosinski ◽  
Anna Di Landro ◽  
Krzysztofa Łuczak-Szymerska ◽  
Emilie Soriano ◽  
Carol Caverzasio ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Chronic Wounds ◽  
Treatment Time ◽  
Complete Healing ◽  
Leg Ulcers ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial ◽  
Mixed Origin ◽  
Chronic Leg Ulcers

Introduction. Hyaluronic acid (HA)-containing formulations routinely are utilized along with standard therapy to promote faster healing of chronic wounds; evidence to guide clinical decisions on the use of topical HA in the healing of vascular leg ulcers is limited. Objective. This study compared the efficacy and safety of an HA-impregnated gauze pad with an identical gauze pad without HA in the treatment of chronic leg ulcers of vascular origin. Materials and Methods. A prospective, multicenter, multinational, parallel-group, randomized, double-blind, clinical study was conducted between June 13, 2017, and December 31, 2018. Adults with 1 or more chronic leg ulcers of venous or mixed origin between 2 months and 4 years’ duration were eligible to participate. Participants were randomized to treatment consisting of standard care (ie, ulcer cleansing, debridement/anesthesia as necessary, and optimized compression) and either application of a gauze pad containing 0.05% HA or a neutral comparator once daily for a maximum of 20 weeks. The primary efficacy endpoint was complete ulcer healing (100% reepithelialization of the wound area centrally assessed by 1 independent and experienced assessor blinded with respect to the treatment applied, as shown on digital photographs taken under standardized conditions at or before 20 weeks and confirmed 3 weeks later). Secondary efficacy endpoints included the percentage of completely healed target ulcers, residual area of target ulcer relative to baseline, the condition of the periulcerous skin, the total amount of analgesics used, the incidence of infection at the ulcer site of the target ulcer, patient adherence to treatment, time to achieve complete healing as centrally assessed, and pain intensity as measured by a visual analog scale. Results. Among the 168 participants (82 in the HA gauze pad group and 86 in the neutral gauze pad group), 33 (39.8%) in the HA group experienced complete healing of the target ulcer, which was significantly higher than the neutral comparator group (15, 18.5%; P = .002). Results in the full analysis and per-protocol sets were consistent with the primary results; no significant difference was noted in outcomes when participants’ wounds were stratified according to baseline ulcer size. Conclusions. HA delivered in a gauze pad formulation could be a beneficial treatment for chronic leg ulcers of venous or mixed origin.

Efficacy and Safety of a Hyaluronic Acid–Containing Cream in the Treatment of Chronic, Venous, or Mixed-Origin Leg Ulcers: A Prospective, Multicenter Randomized Controlled Trial

2021 ◽  
Vol 33 (11) ◽  
pp. 285-295
Author(s):  
Jacek Mikosinski ◽  
Anna Di Landro ◽  
Karolina Kasztalska-Kazmierczak ◽  
Emilie Soriano ◽  
Carol Caverzasio ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Controlled Trial ◽  
Leg Ulcers ◽  
Primary Efficacy ◽  
Primary Efficacy Endpoint ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Mixed Origin ◽  
Chronic Leg Ulcers ◽  
Topical Applications

Introduction. Topical applications of hyaluronic acid (HA)–containing formulations, based on the complex and vital role of HA in all stages of the wound-healing process, are routinely used with standard therapy to promote faster healing of chronic wounds. However, evidence to guide clinical decisions on the use of topical HA in the healing of vascular leg ulcers is limited. Objective. This study compared the efficacy and safety of topical application of a hyaluronic acid cream vs a neutral comparator (identical cream without HA) in treating subjects with chronic leg ulcers of vascular origin. Materials and Methods. This was a prospective, multicenter double-blind randomized controlled trial. One hundred sixty-eight subjects with chronic leg ulcers of venous or mixed (venous and arterial) origin were randomized to receive either topical applications of 0.2% HA cream or neutral comparator cream for a maximum of 20 weeks. The primary efficacy endpoint was complete ulcer healing (100% reepithelialization of the wound area centrally assessed at 20 weeks or before and confirmed 3 weeks later). In both groups, topical treatment was associated with standard therapy (ulcer cleansing and optimized compression). Results. The proportion of subjects with centrally assessed complete healing of the target ulcer that was confirmed 3 weeks later (primary efficacy endpoint) was substantially higher in the HA cream group (31.3%) than in the neutral cream group (14.8%; P =.009). Results in the full analysis, per protocol, and as assessed by the investigator were consistent with primary results. No significant difference in treatment effect was observed when subjects were stratified according to baseline ulcer size (≤20 cm2 or >20 cm2) regardless of topical treatment. Safety and tolerability were comparable between treatments. Conclusions. Treatment of subjects with chronic leg ulcers of venous or mixed origin with HA cream is safe, well tolerated, and results in a higher rate of healing than a neutral comparator cream.

scholarly journals Efficacy of platelet rich plasma in chronic leg ulcers: a prospective randomized controlled study

2020 ◽  
Vol 7 (1) ◽  
pp. 78
Author(s):  
Naphisabet Wanniang ◽  
Pankaj Shukla ◽  
Varadraj V. Pai
Keyword(s):  
Chronic Wounds ◽  
Platelet Rich Plasma ◽  
The United States ◽  
Complete Healing ◽  
Controlled Study ◽  
Control Group ◽  
Leg Ulcers ◽  
The Mean ◽  
Chronic Leg Ulcers ◽  
Area And Volume

<p class="abstract"><strong>Background:</strong> Chronic wounds affect approximately 1-2% of the population in Europe and the United States. Platelet rich plasma (PRP) has emerged as an effective, inexpensive, minimally invasive treatment modality for chronic leg ulcers. Objective of the study was to evaluate the efficacy of PRP, and to compare the effectiveness of PRP to regular antiseptic dressing in the management of chronic leg ulcers.</p><p class="abstract"><strong>Methods:</strong> A hundred patients with chronic leg ulcers of more than 6 weeks duration were randomized into two groups (PRP and conventional dressing group). Patients in the PRP group received weekly intradermal injections of PRP to the wound in addition to conventional daily dressings till complete healing of the ulcers or up to a maximum of 6 weekly PRP sessions. Percentage of improvement in the area and volume of the ulcers were recorded. Patients were followed up at 1 month post PRP treatment.</p><p class="abstract"><strong>Results:</strong> The mean reduction in the area of the ulcers at the end of 6 weeks was 66.39% in the PRP group and 28.6% in the control group. The mean reduction in volume of the ulcers at the end of 6 weeks was 71.80% and 37.88% in the case and control group respectively. At the end of 1 month post treatment follow-up, 74% and 10% of the ulcers treated with PRP and with conventional dressing respectively showed complete healing.</p><p class="abstract"><strong>Conclusions:</strong> Leg ulcers treated with PRP showed a significantly higher reduction in the area and volume of the ulcers compared to ulcers treated with conventional moist dressing.</p>

scholarly journals Safety and efficacy of larval therapy on treating leg ulcers: a protocol for systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039898
Author(s):  
Weijing Fan ◽  
Baozhong Yang ◽  
Xiaoming Hu ◽  
Xiao Yang ◽  
Chenyan Shi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Treatment Time ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Measurement Data ◽  
Complete Healing ◽  
Cochrane Library ◽  
Leg Ulcers ◽  
China National Knowledge Infrastructure ◽  
Larval Therapy

IntroductionLeg ulcers (LUs) not only seriously affect life and work of patients, but also bring huge economic burden to the society. As a potential underused biological debridement, larval therapy provides help for the treatment of LUs. The purpose of our research is to assess whether patients with LUs can benefit from larval therapy.Methods and analysisThe following electronic databases will be searched: PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure Database, Wanfang Database and Chinese Biological Medicine. Randomised controlled trials are eligible for inclusion. There will be no restrictions with respect to language and search date is up to June 2020. Primary outcomes investigated are complete healing rate after treatment, time to ulcer healing, reduction of wound surface area and adverse events. Risk ratios will be used for categorical data; weighted mean difference will be used for measurement data. Subgroup analysis and sensitivity analysis will be considered if heterogeneity exists. The results of data synthesis will be performed by narrative summary and quantitative analysis.Ethics and disseminationThis systematic review does not require the approval of the ethics committee because individual data on patients are not collected. The results of the study will be disseminated in peer-reviewed journals.PROSPERO registration numberCRD42020176953.

Treatment of therapy-refractive ulcera cruris of various origins with autologous keratinocytes in fibrin sealant

VASA ◽  
2005 ◽  
Vol 34 (1) ◽  
pp. 25-29 ◽  
Author(s):  
Johnsen ◽  
Ermuth ◽  
Tanczos ◽  
Bannasch ◽  
Horch ◽  
...  
Keyword(s):  
Observational Study ◽  
Fibrin Sealant ◽  
Chronic Wounds ◽  
Leg Ulcers ◽  
Impaired Wound Healing ◽  
Skin Excision ◽  
The Mean ◽  
High Degree ◽  
Chronic Leg Ulcers ◽  
Suspended Cells

Background: Evaluation of the effects of cultivated, subconfluent, autologous keratinocytes in fibrin sealant (BioSeed®-S) on the healing of therapy-refractive chronic wounds. Patients and methods: Open observational study in 60 patients with chronic leg ulcers and impaired wound healing of various origins. After whole-skin excision and cultivation of the autologous keratinocytes, the suspended cells were applied to the preconditioned wound in fibrin sealant. Wound epithelization and wound size were recorded at defined times. Results: Fifty-two of the 60 participating patients could be evaluated. After 6 weeks, 29 ulcers (55.8%) were healed. The mean epithelization increased between the 8th and 42nd postoperative day from 23% to 62.5%. In 50.0% of the patients, global assessment of the wound showed a high degree of epithelization or healing after 42 days. In 32.6 % of treated patients, improvement was observed, while no healing tendency was to be found in 17.4%. Conclusion: The present observational study indicates that the transplantation of autologous keratinocytes suspended in fibrin sealant could be of advantage in the treatment of refractive leg ulcers.

scholarly journals Measurement and Prediction of Progress in Delayed Wound Healing

1987 ◽  
Vol 80 (4) ◽  
pp. 210-212 ◽  
Author(s):  
C J K Bulstrode ◽  
A W Goode ◽  
P J Scott
Keyword(s):  
Healing Rate ◽  
Close Correlation ◽  
Complete Healing ◽  
Size Change ◽  
Delayed Wound Healing ◽  
Ulcer Size ◽  
Epithelial Migration ◽  
Significant Difference ◽  
The Difference ◽  
Chronic Leg Ulcers

Thirty chronic leg ulcers have been studied under controlled conditions until complete healing occurred. Measurement was performed weekly using a computer-linked stereocamera which is capable of measuring skin defects noninvasively with errors of less than 2%. There was a significant difference in healing rate for the first two weeks between clean ulcers entering the trial directly and ulcers admitted first for cleansing before joining the trial. The difference suggests that the weekly healing rate of an ulcer may take up to 2 weeks to respond to a new form of treatment. Absolute ulcer size, change in ulcer size and rate of epithelial migration did not correlate well with time to complete healing, but percentage change in area in the third week was found to be the parameter which gave the earliest close correlation with time to complete healing. Using this parameter, on the data available it was found that time to complete healing could be predicted to within one week for 50% of the ulcers, making this a simple and useful early predictor of treatment efficiency.

Efficacy and safety of hyaluronic acid in treatment of leg ulcers: a double-blind RCT

2012 ◽  
Vol 21 (3) ◽  
pp. 131-139 ◽  
Author(s):  
O. Dereure ◽  
M. Czubek ◽  
P. Combemale
Keyword(s):  
Hyaluronic Acid ◽  
Leg Ulcers ◽  
Efficacy And Safety ◽  
Double Blind

Efficacy and tolerance of a hydrocolloid dressing containing hyaluronic acid for the treatment of leg ulcers of venous or mixed origin

2008 ◽  
Vol 24 (10) ◽  
pp. 2729-2739 ◽  
Author(s):  
Sylvie Meaume ◽  
Zohra Ourabah ◽  
Marco Romanelli ◽  
Roberto Manopulo ◽  
Florent De Vathaire ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Leg Ulcers ◽  
Hydrocolloid Dressing ◽  
Mixed Origin

scholarly journals Efficacy and Safety of Intra-Articular Hyaluronic Acid Injection (NRD101 / SUVENYL®) in Patients With Knee Osteoarthritis: a Multicenter, Randomized, Double-blind, Parallel, Active Control, Non-Inferiority Clinical Study

2021 ◽  
Author(s):  
Haoyang Wang ◽  
Wei Wang ◽  
Yongsheng Xu ◽  
Jianan Li ◽  
Kang Liu ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Active Control ◽  
Subscale Score ◽  
Chinese Patients ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Pain Subscale ◽  
Significant Difference

Abstract BackgroundIntra-articular injection of hyaluronic acid (HA) has favorable effects on pain relief and knee function along with the low incidence of serious adverse reactions. Although various HA products are available for the treatment of knee osteoarthritis, it is still controversial whether differences in HA products have any clinically significant difference in efficacy and safety. In light of the above, the efficacy and safety of intra-articular injection of biological fermentation–derived high-molecular-weight HA (NRD101) was investigated in a double-blind comparative manner in Chinese patients with knee osteoarthritis.MethodA multicenter, prospective, randomized, double-blind, parallel, active control, non-inferiority study was conducted in Chinese patients with knee osteoarthritis. Patients were randomized to receive five consecutive weekly injections of either NRD101 or Artz (a non-crosslinked low-molecular-weight HA derived from combs of roosters) followed by 4 weeks follow-up. The primary efficacy endpoint was the change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) NRS pain subscale score at Week 5. Secondary efficacy endpoints included WOMAC stiffness and physical function subscale score, local pain, range of joint motion, and overall improvement.ResultsAmong 267 randomized patients, 259 patients completed the study. The change from baseline in WOMAC NRS pain subscale score at Week 5 was −2.98 ± 0.193 in the NRD101 group and −2.66 ± 0.194 in the Artz group, and the trial met the non-inferiority criteria. Efficacy in the NRD101 group tended to be consistently higher than in the Artz group for most items of WOMAC. Several subgroup analyses also showed differences between the two groups, tending to favor NRD101. Adverse events were seen in 26.0% (34/131) of patients in the NRD101 group and 38.3% (51/133) in the Artz group.ConclusionsNRD101 improved knee pain in Chinese patients with osteoarthritis after five consecutive weekly injections. NRD101 tended to be somewhat more effective than Artz. No new safety concerns were identified.Trial registration: JapicCTI, JapicCTI-173531. Registered 10 March 2017, https://www.clinicaltrials.jp/cti-user/trial/Search.jsp

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