The effects of felted foam in diabetic foot treatment: systematic review with meta-analysis

Meneses, Jayana Castelo Branco Cavalcante de; Borges, José Wicto Pereira; Silva, Ana Roberta Vilarouca da; Viana, Maria Corina Amaral; Rebouças, Vitória de Cassia Félix; Alencar, Ana Maria Parente Garcia

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Revista da Escola de Enfermagem da USP

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Review • Rev. esc. enferm. USP 54 • 2020 • https://doi.org/10.1590/S1980-220X2019026903640 copy

The effects of felted foam in diabetic foot treatment: systematic review with meta-analysis^* * Extracted from the dissertation: “Efeitos da espuma de feltro no tratamento do pé diabético: revisão sistemática com metanálise”, Curso de Mestrado Acadêmico em Enfermagem, Universidade Regional do Cariri, 2018.

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective:

To evaluate the effects of felted foam in the treatment of diabetic foot plantar ulcer.

Method:

Systematic review with meta-analysis. Research was conducted in Cochrane Library, PubMed, CINAHL, Science Direct, Web of Science, SCOPUS, IBECS and LILACS. Cochrane Collaboration Risk of Bias Tool was employed to evaluate risk of bias. The meta-analyses were calculated in the program Review Manager, while Grades of Recommendation, Assessment, Development and Evaluation was used for evaluating evidence quality.

Results:

Four clinical essays and two cohorts were included. Mean plantar pressure of individuals exposed to felt was reduced by 10.77 kilopascals (CI 95% −14.92, −6.62; p<0.001).

Conclusion:

Higher reduction of plantar pressure was observed to be associated with the use of felt. Development of new models of relief orthosis with felted foam for plantar pressure is recommended, along with more clinical research elucidating related outcomes.

DESCRIPTORS
Diabetic Foot; Foot Ulcer; Systematic Review; Meta-Analysis

Author/ year (Sample)	Inclusion (IC) and exclusion (EC) criteria	Intervention	Comparison /control	Evaluated outcomes	Baseline participant characteristics						Conclusion
Author/ year (Sample)	Inclusion (IC) and exclusion (EC) criteria	Intervention	Comparison /control	Evaluated outcomes	Age (years)	Gender M/F	BMI¹ 1 Body Mass Index; (Kg/m²)	DM duration (years)	Location/ duration	Area (cm²)	Conclusion
Fleischli et al., 1997⁽²⁴24. Lazzarini PA, Crews RT, van Netten JJ, Bus SA, Fernando ME, Chadwick PJ, et al. Measuring plantar tissue stress in people with diabetic peripheral neuropathy: a critical concept in diabetic foot management. J Diabetes Sci Technol. 2019;13(5):869-80. DOI: https://doi.org/10.1177/1932296819849092 https://doi.org/10.1177/1932296819849092... ⁾ (n = 26)	IC: an active plantar NU² 2 neuropatic ulcer; . EC: no reference.	Insoles made of felted foam plus polyethylene foam associated to a post-operative shoe.	CG⁴ 4 Total contact casts; 1: TCC⁵ 5 Obstructive peripheral artery disease; CG2: pressure relief orthosis DH®; CG3: orthopedic shoe Darco®; CG4: post-operative shoe Darco®.	Plantar pressure reduction.	Hallux 51.6 + 9.3 Forefoot 54.3 + 8.9	Hallux15/4 Forefoot 1/6	Hallux 29.7 + 2.3 Forefoot 31.5 + 6.0	No reference	Hallux e metatarsus (forefoot). Duration: No reference	No reference	Felted foam was the fourth most effective modality for reducing plantar pressure.
Birke et al., 2002⁽⁶6. Birke JA, Pavich MA, Patout CA, Horswell R. Comparison of forefoot ulcer healing using alternative off-loading methods in patients with diabetes mellitus. Adv Skin Wound Care. 2002;15(5):210-5. DOI: 10.1097/00129334-200209000-00006 https://doi.org/10.1097/00129334-2002090... ⁾ (n=120)	IC: new non-surgical treatment NU. EC: post-operative wounds; recurrent non-plantar ulcers in midfoot or heel; osteomyelitis; ischemic wounds.	Felted foam adhered to modified post-operative shoe. Weekly change.	CG1: TCC CG2: modified surgical shoe CG3: modified walking splint; CG4: unspecified.	Reduced healing time; Number of healed ulcers.	IG: 57.5 +12 CG1: 47.3 + 9.1 CG2: 58.2+ 11.5 CG3: 56.5 + 9.6 CG4: 56.8 + 10.5	IG: 9/71 CG1: 7/6 CG2: 23/31 CG3: 14/4 CG4: 2/4	No reference	No reference	Hallux and metatarsus. Duration (days): GE: 149.2 + 153.6 CG1: 183.9 + 142.9 GC2: 67.9 + 99.7 CG3: 98.6 + 114.3 CG4: 150.7 + 168.7	IG: 1.17 + 0.84 CG1: 1.26 + 0.45 CG2: 0.84 + 0.45 CG3: 1.76 + 1.17 CG4: 1.6 + 0.35	There was no significant difference between the intervention and the groups regarding healing time; 81% of NUs healed in 12 weeks.
Zimny et al., 2002⁽⁵5. Zimny S, Meyer MF, Schatz H, Pfohl M. Applied felted foam for plantar pressure relief is an efficient therapy in neuropathic diabetic foot ulcers. Exp Clin Endocrinol Diabetes. 2002;110(7):325-8. DOI: 10.1055/s-2002-34988 https://doi.org/10.1055/s-2002-34988... ⁾ (n=61)	IC: DM 1 or 2, with Wagner's grade 1 or 2 plantar NU. EC: OPAD⁸, mediasclerosis or osteomyelitis.	Felted foam and rubber implanted in post-operational shoe.	Half shoe (Thanner®, Hoechstaedt, Germany).	Reduction in healing time and lesion area.	IG: 61.7 + 13.3 CG: 61.1 + 11.6	IG: 14/13 CG: 19/15	IG: 27.1 + 4.8 CG: 27.9 + 4.4	IG: 18.4 + 7.2 CG: 21.6 + 11.7	Refers neither location nor duration.	IG: 11.1 + 1.4 CG: 11.9 + 1.4	There was no difference in healing time and reduction in wound area among groups.
Zimny; Schatz; Pfohl, 2003⁽⁷7. Zimny S, Schatz H, Pfohl U. The effects of applied felted foam on wound healing and healing times in the therapy of neuropathic diabetic foot ulcers. Diabet Med. 2003;20(8):622-5. DOI: 10.1046/j.1464-5491.2003.01011.x https://doi.org/10.1046/j.1464-5491.2003... ⁾ (n=54)	CI: DM 1 or 2, with plantar NU Wagner's grade 1 or 2. EC: OPAD, mediasclerosis or osteomyelitis.	Rubber foam and felted foam associated to post-operative shoe.	Half-shoe (Thanner®, Hoechstaedt, Germany).	Healing time reduction; lesion area reduction.	IG: 62.1 + 130. CG: 62.1 + 10.8	IG: 13/11 CG: 17/13	IG: 27.4 + 4.9 CG: 28.5 + 4.3	IG: 18.2 + 7.6 CG: 22.1 + 11.8	Metatarsus (forefoot). Duration: no reference.	IG: 10.2 + 4.5 CG: 11.3 + 5.1	Felted foam reduced plantar pressure as effectively as the shoe and contributed more to wound reparation.
Nubé et al., 2006⁽²³23. Nubé VL, Molyneaux L, Bolton T, Clingan T, Palmer E, Yue DK. The use of felt deflective padding in the management of plantar hallux and forefoot ulcers in patients with diabetes. Foot. 2006;16(1):38-43. DOI: https://doi.org/10.1016/j.foot.2005.11.005 https://doi.org/10.1016/j.foot.2005.11.0... ⁾ (n=32)	IC: DM 1 or 2; NU in hallux or metatarsus, Wagner's grade 1A or 1B. EC: impalpable pulsations or ABI <0.6; exudative ulcer with deep sinus.	Felted foam adhered to foot plus proper shoes for diabetic foot.	Felted foam adhered to a proper shoe for diabetic foot; Darco® shoe used in 65% of participants (8 in IG and 13 in CG).	Lesion area reduction. Comparison of healing rates for hallux and forefoot.	IG: 59 (50-70) CG: 56 (55-66)	IG: 14/1 CG: 12/5	No reference	IG: 14 (10-19) CG:12 (6-19)	Hallux e metatarsus (forefoot). Duration: IG: 14 (10-19) CG: 12 (6-19)	IG: 0.5 (0.2-1.3) CG: 0.5 (0.2-0.8)	Reduction of hallux or forefoot ulcer size were similar. There were few adverse events with felt (maceration and mycosis).
Raspovic; Waller; Wong, 2016⁽⁹9. Raspovic A, Waller K, Wong WM. The effectiveness of felt padding for offloading diabetes-related foot ulcers, at baseline and after one week of wear. Diabetes Res Clin Pract. 2016;121:166-72. DOI: https://doi.org/10.1016/j.diabres.2016.09.018 https://doi.org/10.1016/j.diabres.2016.0... ⁾ (n=15)	IC: >18 years; plantar NU⁹ EC: not speaking basic English, not being able to roam for 10 steps; amputation under the knee; OPAD, exposed bone or infection.	New felted foam adhered to foot and associated to All Purpose Boot or post-operative shoe.	CG1: Felted foam worn after seven days of application; CG2: no felt.	Plantar pressure reduction.	55.8 + 10.7	14/1	31.7 + 2.9	11.8 +11.3	Hallux and metatarsus (forefoot), medium and heel. Duration: No reference	0.24 + 0.25	The new felt relieved 49% of plantar pressure in comparison to no felt. Worn felt relieved 32% in comparison to no felt.

EVALUATIONS						N OF PATIENTS		EFFECT	QUALITY OF EVIDENCE	RELATIVE IMPORTANCE OF OUTCOME
Number of studies	Study design	Risk of bias	Inconsistency	Indirect evidence	Inaccuracy	Felted foam	Other discharge techniques	Absolute(95% CI)	QUALITY OF EVIDENCE	RELATIVE IMPORTANCE OF OUTCOME
Plantar pressure reduction (evaluated with the measurement of pressure reduction in kPa)
4	Randomized clinical trials	Not severe	Not severe	Not severe	Severe^a a Broad CI.	56	56	DM: Minus 10.77 kPa(-14.92 to −6.62)	⨁⨁⨁◯ MODERATE	IMPORTANT
Healing time reduction (follow-up: mean of 11 weeks. Evaluated in days)
2	Observational studies	Not severe	Not severe	Not severe	Severe^a a Broad CI.	53	91	DM: Minus 3.71 days(-8.28 to −0.85)	⨁◯◯◯ VERY LOW	IMPORTANT

Universidade de São Paulo, Escola de Enfermagem Av. Dr. Enéas de Carvalho Aguiar, 419 , 05403-000 São Paulo - SP/ Brasil, Tel./Fax: (55 11) 3061-7553, - São Paulo - SP - Brazil
E-mail: reeusp@usp.br

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[1] Corresponding author: Jayana Castelo Branco Cavalcante de Meneses, Rua Wellington Bezerra Pinheiro, 62, Fomento, CEP 63501-636 – Iguatu, CE, Brazil jayanacastelobranco@hotmail.com