Preliminary Clinical Evaluation Using a Novel Bioengineered Wound Product to Treat Lower Extremity Ulcers

Diabetes mellitus affects hundreds of millions of people worldwide, each of which have up to a 25% risk of developing a diabetic foot ulcer (DFU) during their lifetime. With poor DFU healing rates using standard of care, advanced treatments are introduced to attempt to close the wound. The objective of this preliminary clinical evaluation was to evaluate lower extremity ulcers treated with a novel bioengineered wound product (BWP). The BWP, a solid absorbable and conformable sheet composed of gelatin, Manuka honey, and hydroxyapatite, was applied on 12 patients with lower extremity ulcers. The patients in this evaluation spanned across 4 sites and had complicated medical histories, including little to no progression of healing with standard of care or treatment with other biomaterials. The ulcers were treated with debridement, BWP placement, dressing, appropriate compression, and offloading as necessary. Weekly follow-up visits were recommended for evaluation, debridement, and BWP reapplication. Nine patients had the BWP applied to aid in full closure. These patients achieved 100% closure within 8 weeks, with a mean closure time of 4.1 weeks. At 4 weeks, the mean percent wound closure was 94%. Three patients had the BWP applied to aid in achieving a healthy wound bed for continued treatment (eg, splitthickness skin graft) and to cover (epithelialization over) an exposed tendon. In all 12 cases, no treatment site infections were observed. The results and observations from this preliminary clinical evaluation suggest that the BWP supports rapid wound closure, a predictor of complete healing for DFUs.

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Debriding effect of amino acid-buffered hypochlorite on hard-to-heal wounds covered by devitalised tissue: pilot study

Journal of Wound Care ◽

10.12968/jowc.2021.30.6.455 ◽

2021 ◽

Vol 30 (6) ◽

pp. 455-464

Author(s):

Björn Eliasson ◽

Fagerdahl Ann-Mari ◽

Anders Jönsson ◽

Jan Apelqvist

Keyword(s):

Amino Acid ◽

Lower Extremity ◽

Antibacterial Properties ◽

Foot Ulcer ◽

Standard Of Care ◽

Open Label ◽

Intention To Treat ◽

Pilot Investigation ◽

Weekly Application

Objective: Wounds such as lower extremity ulcers are serious, costly and frequently hard to heal. Guidelines conclude that new dressings and treatments generally fail to show superiority compared with standard of care. Several mechanisms are probably responsible for impaired healing of hard-to-heal wounds, including inflammation and infection. Amino acid-buffered hypochlorite has presumed antiseptic and antibacterial properties and has been shown to be useful in the treatment of diabetic foot ulcers (DFUs). We evaluated the debriding effect of amino acid-buffered hypochlorite (ChloraSolv) on full skin hard-to-heal lower extremity ulcers covered with devitalised tissue (≥50%), with six applications over 5 weeks and follow-up at 12 weeks. Method: This was an open-label, single-arm, multicentre, pre-market pilot investigation. We recruited subjects with a lower extremity ulcer, covered with devitalised tissue (≥50%), who were candidates for cleansing and debridement/desloughing. There was a weekly application of the investigational device for five weeks. Follow-up for wound status evaluation was performed at 12 weeks from baseline. Results: We evaluated 57 subjects (33 males, 24 females, median age 73 years, range 51–90 years) (intention-to-treat). Of these, 61.4% had a leg ulcer and 38.6% a foot ulcer. The median wound size at baseline was 7.7cm2 (range 2.1–52cm2) with devitalised tissue coverage of 76.5%. After 5 weeks, a decrease of 72.7% in devitalised tissue was seen, and 71.4% of the subjects showed a decrease in devitalised tissue of ≥50% (evaluated independently using PictZar). At 12 weeks' follow-up the decrease in devitalised tissue was 84.4%. Wound-related pain was reported by ten subjects, resulting in 17 adverse events (AEs). Among these, 12 AEs from eight subjects were recorded as possibly or probably related to the investigational device and one AE was reported to have a causal relationship with the investigational device. Conclusion: This clinical study suggests that amino acid-buffered hypochlorite can be effective and well tolerated in the treatment of hard-to-heal lower extremity ulcers to dissolve and remove devitalised tissue.

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Saline dressing versus povidone iodine dressing in chronic diabetic foot ulcer healing: a prospective comparative study

International Surgery Journal ◽

10.18203/2349-2902.isj20191551 ◽

2019 ◽

Vol 6 (5) ◽

pp. 1524

Author(s):

Srinivas B. Kulkarni ◽

Venkatesh S. ◽

Kruthi S. R.

Keyword(s):

Comparative Study ◽

Surface Area ◽

Diabetic Foot ◽

Povidone Iodine ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Daily Basis ◽

Complete Healing ◽

Prospective Comparative Study ◽

The Mean

Background: Numerous topical agents are used for chronic diabetic foot ulcer (DFU) care and healing. In most of the hospitals in India povidone iodine is used topically for DFU dressing, however few other agents are more efficacious; the present study was aimed to compare the effect of povidone iodine and normal saline dressing in healing of DFU.Methods: A total of 50 patients (25 patients in each arm of povidone Iodine and Saline dressing group) with complaints of chronic DFU attending surgery outpatient department of Rajarajeswari Medical College and Hospital were considered in this prospective comparative study from July 2017 to December 2018. Dressings were done on daily basis for a period of 6 weeks, and the results were compared on 2nd, 4th and 6th week, using reduction in surface area of chronic DFU as parameter of healing process.Results: The mean surface area of wound in povidone iodine group was: baseline- 12.2 sq.cm, 2nd week- 11.7 sq.cm, 4th week- 10.6 sq.cm, 6th week- 9.8 sq.cm; While in saline group was: baseline- 13.3 sq.cm, 2nd week- 11.6 sq.cm, 4th week- 10.8 sq.cm, 6th week- 9.6 sq.cm. After 6 weeks, the mean reduction in surface area of wound is more in the saline dressing group compared with the povidone iodine dressing group and the results are statistically significant at a p<0.05.Conclusions: Saline dressing is more effective than povidone iodine dressing in achieving complete healing, reducing wound surface area, and increasing comfort in subjects with chronic DFU.

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Use of an advanced collagen matrix dressing on patients with complex chronic lower extremity ulcers: A case series

SAGE Open Medical Case Reports ◽

10.1177/2050313x211013684 ◽

2021 ◽

Vol 9 ◽

pp. 2050313X2110136

Author(s):

Afsaneh Alavi ◽

Jeannine Archer ◽

Patricia Coutts

Keyword(s):

Wound Healing ◽

Lower Extremity ◽

Ethylenediaminetetraacetic Acid ◽

Case Series ◽

Standard Of Care ◽

Collagen Matrix ◽

Contact Layer ◽

Complete Healing ◽

Average Decrease

The objective of this case series was to assess the wound healing effectiveness of a collagen matrix wound dressing containing partially denatured collagen, carboxymethyl cellulose, alginate and ethylenediaminetetraacetic acid in chronic lower extremity ulcers. A total of nine patients with refractory lower extremity ulcers were treated with the collagen contact layer in addition to standard of care. Wound healing progress was measured at 2, 4 and 8 weeks. An average decrease in wound size of 73% was achieved across patients at week 8, with complete healing in two patients. The intervention was easy to use and well tolerated by patients. The results of this study, although preliminary, suggest that the advanced collagen matrix dressing represents an effective and safe treatment strategy for healing refractory chronic lower extremity ulcers of varying etiologies. Further investigation is needed to evaluate efficacy in a larger randomized clinical trial with focus on cost-effectiveness and impact on patient’s quality-of-life.

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Estimating Utility Values for Health States of DFU Patients Using EQ-5D-5L and cTTO

The International Journal of Lower Extremity Wounds ◽

10.1177/15347346211014392 ◽

2021 ◽

pp. 153473462110143

Author(s):

Morteza Arab-Zozani ◽

Hossein Safari ◽

Zoha Dori ◽

Somayeh Afshari ◽

Hosein Ameri ◽

...

Keyword(s):

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Economic Modeling ◽

Health State ◽

Health States ◽

Utility Values ◽

The Mean ◽

The Difference ◽

Diabetes Center ◽

Health State Utility Values

Health-state utility values of diabetic foot ulcer (DFU) patients are necessary for clinical praxis and economic modeling. The purpose of this study was to estimate utility values in DFU patients using the EuroQol-5-dimension-5-level (EQ-5D-5L) and composite time trade-off (cTTO). The EQ-5D-5L and cTTO were used for estimating utility values. Data were collected from 228 patients referred to the largest governmental diabetes center in the South of Iran, Yazd province. When appropriate, independent sample t-test or analysis of variance test was used to test the difference in the utility values in each of the demographic and clinical characteristics of the patients. Finally, the BetaMix was used to identify predictors of the utility values. The means of EQ-5D-5L and cTTO values were 0.55( SD 0.21) and 0.67( SD 0.23), respectively. Anxiety and pain were the most common problems reported by the patients. The difference between the mean EQ-5D-5L values was significant for age, grade of ulcer, number of comorbidities, and having complications. In addition, variables of gender, age, grade of ulcer, and having complications were significant predictors of the EQ-5D-5L. The difference between the mean cTTO values was significant for age, employment status, grade of ulcer, number of comorbidities, and having complications. Moreover, variables of gender, age, grade of ulcer, number of comorbidities, and developing complications were significant predictors of cTTO. The current study provided estimates of utility values for DFU patients for clinical praxis and economic modeling. These estimates, similar to utilities reported in other studies, were low. Identifying strategies to decrease anxiety/depression and pain in patients is important to improve the utility values.

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Emerging Diabetic Foot Ulcer Microbiome Analysis using Cutting Edge Technologies

Journal of Diabetes Science and Technology ◽

10.1177/1932296821990097 ◽

2021 ◽

pp. 193229682199009

Author(s):

Brian M. Schmidt

Keyword(s):

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Standard Of Care ◽

Molecular Techniques ◽

Foot Ulcers ◽

Care Practice ◽

Antibiotic Administration ◽

Diabetic Foot Ulcers ◽

Conventional Culture

One of the most prevalent complications of diabetes mellitus are diabetic foot ulcers (DFU). Diabetic foot ulcers represent a complex condition placing individuals at-risk for major lower extremity amputations and are an independent predictor of patient mortality. DFU heal poorly when standard of care therapy is applied. In fact, wound healing occurs only approximately 30% within 12 weeks and only 45% regardless of time when standard of care is utilized. Similarly, diabetic foot infections occur in half of all DFU and conventional microbiologic cultures can take several days to process before a result is known. DFU represent a significant challenge in this regard because DFU often demonstrate polymicrobial growth, become resistant to preferred antibiotic therapy, and do not inform providers about long-term prognosis. In addition, conventional culture yields may be affected by the timing of antibiotic administration and collection of tissue for analysis. This may lead to suboptimal antibiotic administration or debilitating amputations. The microbiome of DFU is a new frontier to better understand the interactions between host organisms and pathogenic ones. Newer molecular techniques are readily available to assist in analyzing the constituency of the microbiome of DFU. These emerging techniques have already been used to study the microbiome of DFU and have clinical implications that may alter standard of care practice in the near future. Here emerging molecular techniques that can provide clinicians with rapid DFU-related-information and help prognosticate outcomes in this vulnerable patient population are presented.

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Diagnostic Utility of Lower Extremity Radiographs of Young Children With Gait Disturbance

PEDIATRICS ◽

10.1542/peds.87.2.138 ◽

1991 ◽

Vol 87 (2) ◽

pp. 138-140

Author(s):

Steven D. Blatt ◽

Bruce M. Rosenthal ◽

Douglas C. Barnhart

Keyword(s):

Lower Extremity ◽

Failure To Thrive ◽

Gait Disturbance ◽

Diagnostic Utility ◽

Duration Of Symptoms ◽

Soft Tissue Swelling ◽

Chief Complaints ◽

The Mean ◽

Limiting Condition

The diagnostic utility of lower extremity radiographs was evaluated using 84 outpatients 1 to 5 years of age with gait disturbance whose lower extremities appeared physically normal. Chief complaints included limp (65 children [77%]), refusal to walk or stand (37 children [44%]), and frequent falling (6 children [7%]). A total of 43 children (51%) had more than one complaint. The mean age of patients was 26 months and the median duration of symptoms was 1 day. Trauma was reported in 43 (51%) cases and fever in 14 (17%). Results of radiographical studies appeared normal in 81 children (96%), demonstrated soft tissue swelling in 2 children, and revealed a bony island in 1 child. In 1 patient admitted to the hospital for failure to thrive and irritability, and whose radiographic results appeared normal, findings consistent with osteomyelitis later developed. Of the remaining children, 68 (81%) were available for follow-up observation 4 to 28 months after the initial visit and all reported spontaneous resolution of the initial complaint. It was concluded that in a well-appearing child with an otherwise normal physical examination results, an acute gait disturbance is likely to be a self-limiting condition and radiographs are unlikely to contribute to the diagnosis.

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Long-Term Outcome after Successful Lower Extremity Free Flap Salvage

Journal of Reconstructive Microsurgery ◽

10.1055/s-0038-1675146 ◽

2018 ◽

Vol 35 (04) ◽

pp. 263-269 ◽

Cited By ~ 5

Author(s):

Amir Bigdeli ◽

Emre Gazyakan ◽

Volker Schmidt ◽

Christoph Bauer ◽

Günter Germann ◽

...

Keyword(s):

Lower Extremity ◽

Free Flap ◽

Free Flaps ◽

Term Outcome ◽

Long Term Outcome ◽

Component Score ◽

Sf 36 ◽

The Mean

Background Vascular occlusion after free flap surgery has become a rare complication but still poses a major challenge. It necessitates urgent re-exploration, but the logistic challenge to provide sufficient resources for the emergency intervention remains. The aim of this study was to analyze the long-term outcome after successful lower extremity free flap salvage. Methods A single-center retrospective study including long-term follow-up was approved by the local ethics committee. From January 1999 to December 2010, a total of 581 free flaps were performed for lower extremity reconstruction. Eighty-six flaps required emergency re-exploration, of which 65 could be salvaged. Fifteen salvaged flaps were excluded from the study because of secondary amputation. Of 50 patients, 29 (6 females and 23 males) were eligible for follow-up. The mean follow-up time was 54.5 ± 32.9 months. Health-related quality of life (Short Form 36 [SF-36]) and scar quality (Vancouver Scar Scale [VSS]) were analyzed. Results The overall flap survival rate was 94.7% and the total loss rate was 5.3%. The re-exploration rate was 14.8% (86 of 581 flaps). The salvage rate was 75.6% (65 of 86 flaps). Twenty-one free flaps were totally lost (24.4%). Partial flap loss occurred in 12 cases (14.0%); 67.5% of the vascular complications occurred during the first 24 hours, 20.9% between 24 and 72 hours, and 11.6% after more than 72 hours. The mean time from the first signs of impaired flap perfusion to re-exploration was 1.3 ± 0.4 hours, and from free tissue transfer to re-exploration was 16.2 ± 1.9 hours. The overall scar appearance was good with an average VSS score of 4.0 points. The average SF-36 physical component score was 54.4 ± 5.4 and the mental component score was 63.1 ± 10.7. Conclusion Careful monitoring and the opportunity for urgent re-exploration are the key to success for free flaps salvage. Following these principles, an acceptable long-term outcome can be achieved.

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The Use of Patient-Specific 3D Printed Titanium Implants for Complex Foot and Ankle Limb Salvage, Deformity Correction, and Arthrodesis Procedures

Foot & Ankle Orthopaedics ◽

10.1177/2473011417s000018 ◽

2017 ◽

Vol 2 (3) ◽

pp. 2473011417S0000

Author(s):

Samuel Adams ◽

Travis Dekker ◽

John Steele ◽

Kamran Hamid

Keyword(s):

Lower Extremity ◽

Deformity Correction ◽

Titanium Implants ◽

Patient Specific ◽

Allograft Bone ◽

Foot And Ankle ◽

Sf 36 ◽

3D Printed ◽

The Mean

Category: Ankle,Ankle Arthritis,Basic Sciences/Biologics,Trauma Introduction/Purpose: Large lower extremity bony defects, complex foot and ankle deformities, and high-risk arthrodesis situations can be difficult to treat. These challenging pathologies, often require a critical-sizes and/or shaped structural bone void filler which may not be available with allograft bone. The advancement of 3D printing technology has allowed for the use of custom designed implants for foot and ankle surgery. This study reports on the radiographic and functional outcomes of a case series of patients treated with patient-specific 3D printed titanium implants. Methods: Seven consecutive patients who were treated with custom designed 3D printed implant cages for severe bone loss, deformity correction, and arthrodesis procedures were included in this study. A minimum of 1-year follow-up was required. No patients were lost to follow-up. Patients completed preoperative and most recent follow-up VAS for pain, FAAM, and SF-36 outcomes questionnaires. All patients had post-operative radiographs and CT scans to assess bony incorporation. Results: The mean age of these patients was 54.6 (35-73 years of age). The mean follow-up of these seven patients was 17.1 months (range 12 to 31). Radiographic fusion with cage ingrowth and integration occurred in all seven patients verified by CT scan. There was statistically significant improvement in all functional outcome score measures (VAS for pain, FAAM, and SF-36). All patients returned were satisfied with surgery. There were no failures. Case examples are demonstrated in Figure 1. Conclusion: This cohort of patients demonstrated the successful use of custom 3D printed implants to treat complex large bony defects, deformities and arthrodesis procedures of the lower extremity. These implants offer the surgeon a patient specific approach to treat both pain and deformity that is not necessarily available with allograft bone.

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Extensive curettage using a high-speed burr versus dehydrated alcohol instillation for the treatment of enchondroma of the hand

Journal of Hand Surgery (European Volume) ◽

10.1177/1753193413517204 ◽

2013 ◽

Vol 40 (4) ◽

pp. 384-391 ◽

Cited By ~ 5

Author(s):

S. M. Cha ◽

H. D. Shin ◽

K. C. Kim ◽

I. Y. Park

Keyword(s):

Analogue Scale ◽

High Speed ◽

Proximal Phalanx ◽

Healing Time ◽

Complete Healing ◽

Pathological Fractures ◽

Active Motion ◽

The Mean ◽

High Speed Burr

The purpose of this retrospective study was to compare the clinical and radiological outcomes of patients treated with different adjuvant methods after curettage for enchondromas of the hand. Sixty-two patients with enchondroma were treated with high-speed burring (29 patients) or alcohol instillation (33 patients) after curettage. The mean follow-up was 40.8 months. No significant differences in the visual analogue scale, Disabilities of the Arm, Shoulder, and Hand scores, total range of active motion, grip strength, and complete healing time were observed between the groups. The distribution of the results of the formula by Wilhelm and Feldmeier were not significantly different between the groups. No surgery-related complications, postoperative pathological fractures, or recurrence was found in either group. For the treatment of enchondroma in the metacarpal and proximal phalanx, alcohol instillation immediately after curettage was as effective as extensive curettage using a high-speed burr.

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