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Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study.

ABSTRACT: 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®) through its enriched alkaline ointment base and the regenerating growth factors of Royal Jelly (RJ) plus the antimicrobial, immune-modulatory nutritional and other biochemical properties of RJ and Panthenol. We conducted this study to test the safety and efficacy of PEDYPHAR ointment as an adjuvant in limb salvage management for patients with limb-threatening diabetic foot wounds. 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: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 (p=0.034* [*indicates it is statistically significant]). Conclusion:We can conclude that PEDYPHAR could be an effective and safe conservative local adjuvant treatment for cases of diabetic foot infection.Registration number in ClinicalTrials.gov: NCT01531517.

SUBMITTER: Yakoot M

PROVIDER: S-EPMC6731465 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study.

Yakoot Mostafa M Abdelatif Mahmoud M Helmy Sherine S

Diabetes, metabolic syndrome and obesity : targets and therapy 20190902

<h4>Background</h4>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<sup>®</sup>) through its enriched alkaline ointment base and the regenerating growth factor ...[more]

PMID: 31564933

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Project description:BackgroundIn August 2010, the Federal Joint Committee (G-BA) decided that negative pressure wound therapy (NPWT) would not be reimbursable in German ambulatory care. This decision was based on reports from the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that there is no convincing evidence in favor of NPWT. The aim of this diabetic foot study (DiaFu study) is to evaluate whether the clinical, safety and economic results of NPWT are superior to the results of standard wound treatment.Methods/designThe DiaFu study is designed as a national, multicenter, randomized controlled clinical superiority trial with a special focus on outpatient care in Germany. Competent patients in inpatient and outpatient care suffering from a chronic diabetic foot wound for a minimum of four weeks may be included in the study. The trial evaluates the treatment outcome of the application of a technical medical device which is based on the principle of NPWT (intervention group) in comparison to standard moist wound therapy (control group). All treatment systems used in the intervention group bear the symbol of free trade capacity in the European Union (CE mark) and will be operated within normal conditions of clinical routine and according to manufacturer's instructions. Primary endpoints are the time to complete wound healing and the rate of wound healing achieved in each group within the maximum study treatment time of 16 weeks. Primary endpoints will be confirmed by blinded assessment of wound photographs.DiscussionThe DiaFu study will provide solid evidence regarding the efficacy and effectiveness of NPWT until 31 December 2014, the date when G-BA plans to decide on future reimbursement of NPWT in both ambulatory and in-hospital care. The study is designed to comply with all quality requirements of G-BA and IQWiG and will contribute to evidence-based wound care in Germany. The study has been initiated by the statutory health insurance companies in Germany and is co-funded by two manufacturers of NPWT systems.Trial registrationClinical Trials.gov registration number: NCT01480362 (date of registration: 23 November 2011).German Clinical Trials Register number: DRKS00003347 (date of registration: 22 November 2011).

Project description:BackgroundAutologous cell therapy (ACT) is a new treatment method for patients with diabetes and no-option chronic limb-threatening ischemia (NO-CLTI). We aimed to assess the impact of ACT on NO-CLTI in comparison with standard treatment (ST) in a randomized controlled trial.MethodsDiabetic patients with NO-CLTI were randomized to receive either ACT (n=21) or ST (n=19). After 12 weeks, those in the ST group, who did not improve were treated with ACT. The effect of ACT on ischemia and wound healing was assessed by changes in transcutaneous oxygen pressure (TcPO2) and the number of healed patients at 12 weeks. Pain was evaluated by Visual Analogue Scale (VAS). Amputation rates and amputation-free survival (AFS) were assessed in both groups.ResultsDuring the first 12 weeks, TcPO2 increased in the ACT group from 20.8 ± 9.6 to 41.9 ± 18.3 mm Hg (p=0.005) whereas there was no change in the ST group (from 21.2 ± 11.4 to 23.9 ± 13.5 mm Hg). Difference in TcPO2 in the ACT group compared to ST group was 21.1 mm Hg (p=0.034) after 12 weeks. In the period from week 12 to week 24, when ST group received ACT, the TcPO2 in this group increased from 20.1 ± 13.9 to 41.9 ± 14.8 (p=0.005) while it did not change significantly in the ACT in this period. At 24 weeks, there was no significant difference in mean TcPO2 between the two groups. Wound healing was greater at 12 weeks in the ACT group compared to the ST group (5/16 vs. 0/13, p=0.048). Pain measured using VAS was reduced in the ACT group after 12 weeks compared to the baseline, and the difference in scores was again significant (p<0.001), but not in the ST group. There was no difference in rates of major amputation and AFS between ACT and ST groups at 12 weeks.ConclusionsThis study has showed that ACT treatment in patients with no-option CLTI and diabetic foot significantly improved limb ischemia and wound healing after 12 weeks compared to conservative standard therapy. Larger randomized controlled trials are needed to study the benefits of ACT in patients with NO-CLTI and diabetic foot disease.Trial registrationThe trial was registered in the National Board of Health (EudraCT 2016-001397-15).

Project description:ObjectiveThe Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system was developed to stratify the risk of 1-year major amputation. Recently, the WIfI scores were used to define the estimated revascularization benefit quartiles ranging from high benefit (Q1) to questionable benefit (Q4). The aim of our study was to evaluate the revascularization benefit quartiles in a cohort of diabetic patients presenting with chronic limb-threatening ischemia (CLTI).MethodsAll diabetic patients presenting to our multidisciplinary diabetic foot and wound clinic (June 2012 to May 2020) who underwent lower extremity revascularization for CLTI were included. The affected limbs were graded using the WIfI system and assigned to an estimated benefit of revascularization quartile as previously published. One-year major amputation, complete foot healing, secondary patency, and amputation-free survival were calculated among the quartiles using Kaplan-Meier curve analyses and compared using Cox proportional hazards models.ResultsOverall, 136 diabetic patients underwent revascularization of 187 limbs (mean age, 64.9 ± 11.2 years; 63.2% male; 58.8% black). The limbs were revascularized using an endovascular approach for 66.8% and open surgery for 33.2%. Of the 187 limbs, 27.3% had a high estimated benefit of revascularization (Q1), 31.6% had a moderate estimate benefit of revascularization (Q2), 20.3% had a low estimated benefit of revascularization (Q3), and 20.9% had a questionable benefit of revascularization (Q4). The estimated 1-year major amputation rates were 7.2% ± 4.1% for Q1, 3.8% ± 2.6% for Q2, 7.0% ± 4.8% for Q3, and 25.7% ± 7.5% for Q4 (P = .006). The estimated 1-year foot healing rates were 87.3% ± 5.7% for Q1, 84.8% ± 5.6% for Q2, 83.8% ± 7.4% for Q3, and 68.2% ± 9.1% for Q4 (P = .06). The overall secondary patency (P = .23) and amputation-free survival (P = .33) did not significantly differ among the groups. Using Cox proportional hazard modeling, the Q4 group had a significantly greater risk of major amputation compared with Q1 (hazard ratio, 4.26; 95% confidence interval, 1.15-15.70). Of the 14 limbs requiring major amputation, 9 (56.3%) had a patent revascularization at the time of amputation, including one of three limbs in Q1, two of two limbs in Q2, no limb in Q3, and six of nine limbs in Q4.ConclusionsThe questionable estimated revascularization benefit quartile using the WIfI classification system is significantly associated with 1-year major amputation in diabetic patients presenting with CLTI. Limbs with a questionable benefit of revascularization (Q4) will frequently require major amputation despite a patent revascularization, suggesting that the wound size and infection burden are the driving factors behind the elevated risk of major amputation in this group. Our findings support the previously described use of the WIfI classification system to predict revascularization benefit among diabetic patients with CLTI.

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Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study.

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Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study.

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